[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-adenocarcinoma":645},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,55,84,105,125,146,168,197,222,251,284,316,335,358,378,399,421,446,479,500,521,544,574,601,620],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100603974",false,"NCT07143487","Family Communications After Genetic Testing","Evaluation of Provider vs. Patient Mediated Cascade Genetic Testing of First-Degree Relatives of Patients With Newly Diagnosed Colorectal Cancer","Inclusion Criteria:\n\n* STEP 1 PROBANDS: Age \\>= 18 years\n* STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV\n\n  * Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into\u002Finvolve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary\n  * Patients with more than one primary colon adenocarcinoma are eligible\n* STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer\n* STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers\n* STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible\n* STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes\n* STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis\n* STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish\n* STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members\n\n  \\* No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician\n* STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene\n* FDRs: Age \\>= 18 years\n* FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes\n* FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents\n* FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish\n\nExclusion Criteria:\n\n\\-",true,"ALL","18 Years",{"count":20,"type":21},4186,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Colon Adenocarcinoma","Colorectal Adenocarcinoma","Rectal Adenocarcinoma","Stage I Colon Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Rectal Cancer AJCC v8","Stage II Colon Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Rectal Cancer AJCC v8","Stage III Colon Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","Stage IV Colon Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Rectal Cancer AJCC v8","RECRUITING","2026-07-01",{"date":45,"type":46},"2026-07-02","ACTUAL",{"date":48,"type":46},"2026-04-06",{"date":50,"type":21},"2032-11-05",{"name":52,"class":53},"Alliance for Clinical Trials in Oncology","OTHER",276,{"id":56,"slug":4,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100585873","NCT06908031","SCRT+mFOLFOX6+PD-1 Antibody and Targeted Therapy for High-Risk pMMR\u002FMSS Rectal Cancer(CRIT)","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Prospective, Multicenter Phase II Study(CRIT)","CRIT","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   1. White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   2. Hemoglobin (HGB) ≥80 g\u002FL;\n   3. Platelets (PLT) ≥100×10\\^9\u002FL;\n   4. Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range;\n   5. Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range;\n   6. Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.","75 Years",{"count":64,"type":21},49,[66],"PHASE2","To explore the efficacy and safety of short-course radiotherapy combined with mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS\u002FBRAF Wild-Type)\u002Fbevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma through a prospective study, providing high-level evidence-based medical evidence for the use in the treatment of high-risk rectal cancer.",[29,69,70],"High-Risk Cancer","MSS",[72,73,74],"Short-Course Radiotherapy","Targeting Therapy","Immunotherapy","2026-06-30",{"date":43,"type":46},{"date":78,"type":46},"2025-04-02",{"date":80,"type":21},"2027-04-01",{"name":82,"class":53},"Sixth Affiliated Hospital, Sun Yat-sen University",1,{"id":85,"slug":4,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":83},"100635185","NCT07549399","SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR\u002FMSS RC","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial","CRITⅡ","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   * White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n\n     * Hemoglobin (HGB) ≥80 g\u002FL; ③Platelets (PLT) ≥100×10\\^9\u002FL; ④Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range; ⑤Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range; ⑥Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":92,"type":21},204,[94],"PHASE3","To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS\u002FBRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR\u002FMSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.",[29,69,70],[72,73,74],"2026-06-29",{"date":43,"type":46},{"date":101,"type":46},"2026-05-20",{"date":103,"type":21},"2029-04-30",{"name":82,"class":53},{"id":106,"slug":4,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":83},"100576092","NCT06780787","FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery","Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n* Histologically confirmed adenocarcinoma of the rectum\n* Rectal involvement defined as involvement of the rectum within 12 cm proximal from anal verge\n* Radial margin of at least 3mm from the mesorectal fascia, with no threatened circumferential tumor margin based on MRI. No more than 4 lymph nodes (LN) with short axis \\> 1 cm\n* T3N0, or TxN1 or TxN2 clinical stage based on MRI staging\n* No evidence of distant metastatic disease based on imaging studies including CT chest and CT or MRI of abdomen and pelvis\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Without bone marrow involvement: Platelets ≥ 100,000\u002Fmm\\^3\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine \\\u003C 1.5 x ULN or clearance of ≥ 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 9 months for women, and at least 6 months for men, after the last dose of oxaliplatin therapy. If patients discontinue oxaliplatin more than 9 months (females) or 6 months (males) before discontinuation of balstilimab and\u002For botensilimab, females and males of childbearing potential must use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of balstilimab and\u002For botensilimab\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Any treatment for rectal cancer prior to enrollment that includes (but not limited to) chemotherapy, radiation, and\u002For biological therapy\n* Any prior immunotherapy\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Prior allogeneic organ transplantation\n* Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement or biopsies\n* Concurrent malignancy other than the diagnosis of rectal cancer, with the exception of curatively resected non-melanoma skin cancer, cervical cancer in situ, prostate cancer Gleason 6 or below that is localized to the prostate, or any other curatively resected cancer from which the patient remains in remission for at least 2 years without treatment\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation\n* Clinically significant uncontrolled illness\n* Females only: Pregnant or breastfeeding\n* Prior allergic reaction or hypersensitivity to any of the study drug components\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs (excluding hypothyroidism, vitiligo, and psoriasis that is controlled with topical management)\n* History of acute thrombotic venous events in the last 30 days before enrollment. If within 30 days, the patient should be on anticoagulants and without symptoms\n* Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study\n* History or current evidence of any condition, co-morbidity, therapy, any active infections (requiring antibiotics), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Known previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 10 days for mild or asymptomatic infections or 20 days for severe\u002Fcritical illness prior to cycle 1 day 1 (C1D1)\n* Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required\n* Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV deoxyribonucleic acid (DNA) for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required\n* Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required\n* Grade 2 or above neuropathy at the time of enrollment\n* Dependence on total parenteral nutrition or intravenous hydration\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":112,"type":21},26,[66],"This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.",[29,116,38],"Stage IIA Rectal Cancer AJCC v8","2026-06-25",{"date":98,"type":46},{"date":120,"type":46},"2025-05-20",{"date":122,"type":21},"2027-11-05",{"name":124,"class":53},"City of Hope Medical Center",{"id":126,"slug":4,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":83},"100644020","NCT07669220","A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR\u002FMSS Lower Rectal Adenocarcinoma (STAR Trial)","STAR","Inclusion Criteria:\n\n1. Before implementing any procedures related to the study protocol rather than routine clinical care, a signed and dated informed consent form must be obtained from the subject voluntarily, in accordance with regulatory requirements and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma.\n4. The lower edge of the rectal tumor is located below the peritoneal reflection.\n5. Locally advanced disease with high-risk factors, meeting at least one of the following: cT4 \u002F cN2 \u002F EMVI+ \u002F MRF+ \u002F positive lateral lymph node.\n6. No clear evidence of distant metastasis prior to treatment.\n7. No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status 0-1 (Appendix 1).\n9. Peripheral blood counts and liver and renal function within the following ranges (tested within 15 days before treatment initiation):\n\n   * White blood cell count (WBC) ≥ 3.0 × 10⁹\u002FL or absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n\n     * Hemoglobin (HGB) ≥ 80 g\u002FL; ③ Platelet count (PLT) ≥ 100 × 10⁹\u002FL; ④ Hepatic transaminases (AST\u002FALT) \\\u003C 3.0 × upper limit of normal (ULN); ⑤ Total bilirubin (TBIL) \\\u003C 1.5 × ULN; ⑥ Creatinine (CREAT) \\\u003C 1.5 × ULN.\n10. No history of other concurrent malignancies; not pregnant or lactating; effective contraceptive methods should be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergy (including allergy to platinum agents, 5-FU, and 5-HT3 receptor antagonists).\n2. Patients who have participated in or are currently participating in another clinical trial within 4 weeks prior to enrollment.\n3. History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other therapy specifically targeting T-cell co-stimulation or checkpoint pathways.\n4. Severe electrolyte abnormalities.\n5. Presence of gastrointestinal diseases such as active gastric or duodenal ulcer, ulcerative colitis, or unresected tumor with active bleeding; or other conditions that may cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment.\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding tendency or hemorrhagic history within 2 months; currently receiving high-dose anticoagulation therapy.\n7. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test prior to the first dose; or female participants and their partners who are unwilling to practice strict contraception during the study period.\n8. Presence of other concurrent or prior active malignancies (except for malignancies that have been curatively treated with no recurrence for more than 3 years, or carcinoma in situ that can be cured by adequate treatment).\n9. Severe electrocardiogram abnormalities, or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or congestive heart failure of NYHA Class II or higher.\n10. Patients with active infection (infection causing fever \\> 38°C).\n11. Patients with poorly controlled hypercalcemia, hypertension, or diabetes mellitus.\n12. Patients with severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).\n13. Patients with mental disorders affecting clinical treatment or a history of central nervous system disease.\n14. Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.).\n15. Presence of any unresolved toxicity of CTCAE Grade 2 or higher resulting from prior therapy (except for anemia, alopecia, and skin pigmentation).\n16. Any medical condition that is unstable or may affect patient safety and compliance with the study.\n17. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.",{"count":132,"type":21},76,[66],"This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR\u002FMSS lower rectal adenocarcinoma, aiming to provide high-level evidence supporting a novel treatment paradigm.",[29,136,137,74,138],"High-risk Locally Advanced","Short-course Radiotherapy (SCRT)","FOLFOX","2026-06-21",{"date":117,"type":46},{"date":142,"type":46},"2026-01-01",{"date":144,"type":21},"2028-01-01",{"name":82,"class":53},{"id":147,"slug":4,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":167},"100592750","NCT06997497","A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012\u002FKANDLELIT-012)","A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer \\[AJCC\\] eighth edition) colorectal adenocarcinoma\n* Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period\n* Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy\n* Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis or leptomeningeal disease\n* Has active infection requiring systemic therapy\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease",{"count":153,"type":21},477,[94],"Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.\n\nStandard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies.\n\nThe goals of this study are to learn:\n\n* About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments\n* If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.",[27,29],"2026-06-11",{"date":159,"type":46},"2026-06-15",{"date":161,"type":46},"2025-07-16",{"date":163,"type":21},"2030-10-27",{"name":165,"class":166},"Merck Sharp & Dohme LLC","INDUSTRY",200,{"id":169,"slug":4,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":175,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":185,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":193,"leadSponsor":195,"locationsCount":83},"100619169","NCT07341126","Use of a Novel Camera to Check the Bowel After Polyp or Tumour Removal","Surveillance Digital Rectoscopy After Local Excision of Rectal Tumours","R-ALERT","Inclusion Criteria:\n\nAll participants who are capable of giving informed consent. All participants aged 16 years or over. All patients must have had a rectal tumour\u002F polyp removed within easy reach of the rigid sigmoidoscope.\n\nAll participants must be resident in the United Kingdom.\n\nExclusion Criteria:\n\nUnable to give informed consent. Under the age of 16 years","16 Years",{"count":177,"type":21},30,"OBSERVATIONAL","1.1 Polyps or tumours in the lower part of the bowel (rectum) can be removed using instruments inserted through the bottom which avoids major surgery and the possibility of a stoma bag (colostomy). Afterwards, it is important to check the area with regular camera tests. If checks are delayed, re-growths could be serious and may be untreatable. COVID and other factors have led to long waiting lists for camera checks and in NHS Lothian around 20% of all camera checks are done more than 6 months late.\n\nThe investigators want to try a new camera and approach that would allow us to reduce waiting lists. Using a short camera called a 'rectoscope' to check the lower bowel has already been shown to be safe, comfortable and acceptable to patients with other conditions. In fact, patients are unlikely to feel or realise any difference between the rectoscope and standard camera tests.\n\nThe investigators want to show that this 'rectoscope' can be safely used in the outpatient clinic with an enema (suppository) instead of strong bowel medicine taken by mouth the day before. This would mean the camera checks happen on time and would reduce waiting lists for other important tests.\n\nThe investigators will include 30 patients across three stages of our study. In the first set of patients, the investigators will use the rectoscope alongside the usual endoscope in the endoscopy room using the usual oral bowel medicine. This stage will check the rectoscope is acceptable to the patient and the doctor. In the next 10 patients the investigators will use a suppository instead of oral bowel medicine still using both cameras. Finally, the investigators will use the rectoscope in the outpatient clinic with an suppository to show this is an easy, effective and acceptable way to deliver timely camera checks.",[181,182,183,29,184],"Bowel Cancer","Polyp Rectal","Rectal Cancer","Rectal Adenoma",[186,187],"LumenEye","Rectoscopy","NOT_YET_RECRUITING","2026-05-28",{"date":191,"type":46},"2026-05-29",{"date":43,"type":21},{"date":194,"type":21},"2027-05-01",{"name":196,"class":53},"University of Edinburgh",{"id":198,"slug":4,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":83},"100331390","NCT03594630","Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer","Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of rectal adenocarcinoma\n* Eligible for curative resection of rectal adenocarcinoma\n* Rectal tumor location =\\\u003C 12 cm from the anal verge as determined by endoscopy or magnetic resonance imaging (MRI) (if endoscopy report is not available or deemed inadequate my treating oncologist)\n* Nodal involvement confined to the radiation field\n* Radiologically measurable or clinically evaluable disease as defined in the protocol\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1 or 2\n* Clinical Stage: Stage II and III. N2 disease is to be estimated as four or more lymph nodes that are \\>= 10 mm. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon including digital rectal exam (DRE), computed tomography (CT) or positron emission tomography (PET)\u002FCT scan of the chest\u002Fabdomen\u002Fpelvis and a pelvic MRI. If a pelvic MRI is performed, it is acceptable to perform CT of the chest\u002Fabdomen, omitting CT imaging of the pelvis. PET\u002FCT is optional.\n* No known contraindication to standard (fluoropyrimidine-based) pelvic chemoradiation (e.g. dihydropyrimidine dehydrogenase \\[DPD\\] deficiency)\n* Patient of child-bearing potential is willing to employ adequate contraception during treatment and after treatment, as directed by treating clinical team\n* Willing to provide written informed consent\n* Willing to return to enrolling medical site for all study assessments\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease (IBD)\n* Diagnosis of MSI-H colorectal cancer at time of consent\n* Recurrent rectal cancer\n* Tumor is causing symptomatic bowel obstruction (patients who have diverting ostomy are eligible)\n* Any prior pelvic radiation\n* Other invasive malignancy undergoing active treatment. Patients receiving prior treatment that precludes standard chemoradiation or ability to receive consolidation\u002Fadjuvant chemotherapy will be excluded from survival analyses\n* Patients unwilling or unable to undergo pelvic MRI",{"count":204,"type":21},120,[206],"EARLY_PHASE1","This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.",[29,35,116,209,210,38,211,212,213],"Stage IIB Rectal Cancer AJCC v8","Stage IIC Rectal Cancer AJCC v8","Stage IIIA Rectal Cancer AJCC v8","Stage IIIB Rectal Cancer AJCC v8","Stage IIIC Rectal Cancer AJCC v8","2026-05-18",{"date":101,"type":46},{"date":217,"type":46},"2024-03-13",{"date":219,"type":21},"2026-10-31",{"name":221,"class":53},"M.D. Anderson Cancer Center",{"id":223,"slug":4,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":235,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100490930","NCT05672524","A Study of Tucatinib and Trastuzumab in People With Rectal Cancer","A Phase II Study of Induction Tucatinib and Trastuzumab With Total Neoadjuvant Therapy for Locally Advanced HER2-amplified Rectal Adenocarcinoma","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for the trial.\n* Be ≥18 years of age on the date of signing informed consent.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed rectal adenocarcinoma.\n* Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3\u002FcT4 N0 or cT(any) cN1\u002F2,\n* No evidence of distant metastases\n* Radiologically measurable or clinically evaluable disease per Protocol Section 13.0.\n* Have confirmed HER2-positive rectal adenocarcinoma, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, meeting at least one of the following criteria:\n\n  1. HER2+ overexpression (3+ immunohistochemistry \\[IHC\\]) by an FDA-approved HER2 IHC test following the package insert's interpretational manual for gastric cancer\n  2. HER2 2+ IHC is eligible if the tumor is amplified by an FDA-approved HER2 in situ hybridization assay (FISH or chromogenic in situ hybridization \\[CISH\\]) following the package insert's interpretational manual for gastric cancer\n  3. HER2 (ERBB2) amplification by CLIA-certified Next Generation Sequencing (NGS) sequencing assay.\n* Tumor specimen that demonstrates intact mismatch repair enzymes by immunohistochemistry or microsatellite stability as demonstrated by NGS or PCR.\n* Tumor specimen that indicates RAS wild-type based on expanded RAS testing including KRAS exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146)\n* Left ventricular ejection fraction \\>=50 assessed by echocardiography\n* Negative pregnancy test done within 14 days prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception is required for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\nNonchildbearing potential is defined as follows (by other than medical reasons):\n\n* ≥45 years of age and has not had menses for \\>1 year\n* Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.\n* Demonstrate adequate organ function as defined in the Table 6-1 below within 14 days of Cycle 1 Day 1, all screening labs should be performed within 14 days of treatment initiation.\n\n  * Absolute neutrophil count (ANC): ≥1,500 \u002Fmm3\n  * Platelets: ≥100,000 \u002F mcL\n  * Hemoglobin: \\>9 g\u002FdL or ≥5.6 mmol\u002FL\n  * Serum creatinine OR Measured or calculated creatinine clearance (Creatinine clearance should be calculated per institutional standard.) (GFR can also be used in place of creatinine or CrCl): ≤1.5 × upper limit of normal (ULN) OR ≥60 mL\u002Fmin for subject with creatinine levels \\> 1.5 × institutional ULN\n  * Serum total bilirubin: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with known Gilbert's disease who may enroll if the conjugated bilirubin is ≥1.5 x ULN\n  * AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): For patients not taking warfarin: INR \\\u003C1.5 or PT \\\u003C1.5 x ULN; and either PTT or aPTT \\\u003C1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR \\\u003C3.5\n\nExclusion Criteria:\n\n* Recurrent rectal cancer.\n* Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.\n* Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).\n* Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.\n* Active infection requiring systemic therapy.\n* Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF\u002FFlk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n* Known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies)\n* Known active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Any known chronic (non-transient) liver disease in the patient's past medical history such as (but not limited to) cirrhosis, NASH (non-alcoholic steatohepatitis) or NAFLD.\n* Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.\n* Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n* Received a live vaccine within 30 days of planned start of study medication.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n* Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Use of a strong cytochrome P450 (CYP)2C8 inhibitor that is not adequately cleared (five half-lives of elapsed time) before study initiation. In addition, use of a strong CYP3A4 or CYP2C8 inducer that is taken within 5 days prior to the first dose of study will also be an exclusion criteria.",{"count":5,"type":21},[66],"The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin\u002FFOLFOX), may help participants with rectal cancer.",[232,233,29,234,183],"Adenocarcinoma of the Rectum","Locally Advanced Rectal Adenocarcinoma","HER2 Positive Rectal Adenocarcinoma",[236,237,232,233,29,183,238,239,240,241],"HER2 positive rectal adenocarcinoma","Adenocarcinoma","Tucatinib","Trastuzumab","Memorial Sloan Kettering Cancer Center","22-185","2026-05-11",{"date":244,"type":46},"2026-05-12",{"date":246,"type":46},"2022-12-30",{"date":248,"type":21},"2030-07-31",{"name":240,"class":53},7,{"id":252,"slug":4,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":266,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},"100375230","NCT04165772","Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors","A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for the trial.\n* Be ≥18 years of age on the date of signing informed consent.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed locally advanced solid tumor (Cohorts 1 \\& 2)\n* Histologically confirmed endometrial cancer (Cohort 3)\n* Solid tumors that in standard practice would be treated with neoadjuvant therapy or surgery (depending on tumor type) (Cohorts 1 \\& 2)\n* Endometrial cancer that is clinically FIGO 2009 Stage I or II (Cohort 3).\n* No evidence of distant metastases.\n\n  * Radiologically measurable or clinically evaluable disease\n* Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry or microsatellite instability as demonstrated by NGS or PCR.\n* Negative pregnancy test done 72 hours prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception, for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\n  1. For Cohort 3, the use of a combination estrogen\u002Fprogesterone contraceptive is allowed; the use of progesterone-only methods including hormone (progestin) releasing IUD, depot medroxyprogesterone acetate, and progestin-only birth control pills is not allowed.\n\nNonchildbearing potential is defined as follows (by other than medical reasons):\n\n* ≥45 years of age and has not had menses for \\>1 year\n* Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.\n\n  * Participant receiving corticosteroids may continue if their dose is stable for least 4 weeks prior to initiating protocol therapy.\n  * Has QTcF ≤ 450 msec, or ≤ 480 msec for participants with bundle branch block.\n  * Demonstrate adequate organ function as defined below within 14 days of Cycle 1, Day 1, all screening labs should be performed within 14 days of treatment initiation.\n  * Hematological\n* Absolute neutrophil count (ANC) ≥1,500 \u002FmcL\n* Platelets ≥100,000 \u002F mcL\n* Hemoglobin \\>9 g\u002FdL or ≥5.6 mmol\u002FL\n\n  * Renal\n* Serum creatinine OR Measured or calculated(a) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal (ULN) OR ≥60 mL\u002Fmin for subject with creatinine levels \\> 1.5 × institutional ULN\n\n  * Hepatic\n* Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN\n\n  * Coagulation\n* International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended (a) Creatinine clearance should be calculated per institutional standard.\n\nExclusion Criteria:\n\n* Presence of metastatic or recurrent disease\n* Prior radiation therapy, chemotherapy, or surgery for tumor\n\n  a. NOTE: For Cohort 3, patients are allowed to have received prior hormonal therapy for treatment of endometrial hyperplasia and\u002For endometrial cancer. Hormonal therapy must be discontinued at least 1-week prior to first dose of study treatment (dostarlimab).\n* For patients with colorectal primary -Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).\n* Cohort 1 Only: Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non- physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment.\n* Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents at non-physiologic doses.\n* Active infection requiring systemic therapy.\n* Cohort 1 \\& 3: Received prior therapy with an antibody or drug specifically targeting T- cell co-stimulation or checkpoint pathways.\n* Experienced ≥ Grade 3 immune-related AE with prior immunotherapy, except for non-clinically significant lab abnormalities.\n* Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF\u002FFlk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n* Known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies)\n* Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.\n* Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n* Received a live vaccine within 30 days of planned start of study medication.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n\n  a. NOTE: For Cohort 3: endometrial sampling (e.g., biopsies, dilatation and curettage), is NOT considered major surgical procedure.\n* History of interstitial lung disease.\n* Known hypersensitivity to TSR-042 components or excipients.",{"count":258,"type":21},212,[66],"The purpose of this study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study drug.",[29,262,263,264,265],"Clinical Stage: Stage II (T3-4, N-)","Stage III (Any T, N+)","Solid Tumor","Solid Tumor, Adult",[267,268,269,270,271,272,273,274],"PD1 blockade","TSR-042","Radiation","Capecitabine","5-FU","19-288","Solid tumor","Dostarlimab","2026-05-08",{"date":277,"type":46},"2026-05-13",{"date":279,"type":46},"2019-12-11",{"date":281,"type":21},"2026-11-30",{"name":240,"class":53},10,{"id":285,"slug":4,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":83},"100634758","NCT07543848","A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer","A Prospective, Multicenter, Single-Arm Phase II Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (cT1-3N0M0)","Inclusion Criteria:\n\n\\- Participants must meet all of the following criteria:\n\n1. Age 18 to 80 years, male or female.\n2. Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge.\n3. Clinical stage T1-3N0M0 according to AJCC staging criteria.\n4. Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing.\n5. No prior anti-tumor treatment.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of at least 3 months.\n7. Adequate organ function, including:\n\n   * Absolute neutrophil count ≥1.5 × 10\\^9\u002FL\n   * Platelet count ≥100 × 10\\^9\u002FL\n   * Hemoglobin ≥9 g\u002FdL\n   * Serum albumin ≥3 g\u002FdL\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN)\n   * ALT and AST ≤2 × ULN\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin\n   * INR or PT ≤1.5 × ULN, and aPTT ≤1.5 × ULN\n8. Thyroid function within normal range or adequately controlled.\n9. Negative pregnancy test for women of childbearing potential.\n10. Willingness to use effective contraception during the study and for 12 months after treatment.\n11. Ability to understand and willingness to sign a written informed consent form.\n12. Willingness and ability to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Participants will be excluded if they meet any of the following criteria:\n\n  1. Histology other than rectal adenocarcinoma (e.g., gastrointestinal stromal tumor, lymphoma).\n  2. Prior pelvic radiotherapy.\n  3. Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors.\n  4. Known allergy to study drugs or their components.\n  5. History of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma.\n  6. Active autoimmune disease or history of autoimmune disease requiring systemic treatment.\n  7. Immunodeficiency, including HIV infection, or history of organ transplantation.\n  8. History of interstitial lung disease or non-infectious pneumonitis.\n  9. Active tuberculosis infection or history of untreated tuberculosis.\n  10. Active hepatitis B or hepatitis C infection.\n  11. Severe cardiovascular, pulmonary, or renal disease.\n  12. Uncontrolled hypertension despite medication.\n  13. History of substance abuse (alcohol or drugs).\n  14. Active uncontrolled infection.\n  15. Use of systemic immunosuppressive therapy.\n  16. Pregnant or breastfeeding women.\n  17. Any condition that, in the investigator's opinion, may interfere with study participation or safety.","80 Years",{"count":292,"type":21},20,[66],"This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).\n\nIn this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment.\n\nThe primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety.\n\nThe results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.",[296,29],"Rectal Neoplasms",[183,298,299,300,301,302,303,304,305,306],"Total Neoadjuvant Therapy","Combination Therapy","Serplulimab","PD-1 Inhibitor","Oncolytic Virus H101","XELOX Chemotherapy","Short-course Radiotherapy","Organ Preservation","Clinical Complete Response","2026-04-15",{"date":309,"type":46},"2026-04-22",{"date":311,"type":21},"2026-05-01",{"date":313,"type":21},"2028-12-31",{"name":315,"class":53},"Chongqing University Cancer Hospital",{"id":317,"slug":4,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":83},"100559840","NCT06569368","Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy","A Phase II Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy","Inclusion Criteria:\n\n* Participants with locally advanced rectal cancers (T3, T4, or N+ disease) with decision to treat with total neoadjuvant therapy.\n* No previous cycles of cytotoxic chemotherapy in management of the index tumor.\n* Age ≥18 years. Because of dosing differences between pediatric and adult populations and the introduced variability with these regiments to the study's primary outcomes, participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤2 (Karnofsky ≥60%,)\n* Participants must have adequate organ and marrow function as defined below:\n\nabsolute neutrophil count ≥1,000\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN\n\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with unresectable distant metastases are ineligible.\n* Participants with unresectable primary tumors are ineligible.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of metronidazole on the developing human fetus are unknown. For this reason and because B2 agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Both English and non-English-speaking participants will be eligible for inclusion in the trial.\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or radiotherapy within 1 year prior to entering the study.\n* Participants who are receiving any other investigational agents.\n* Participants with brain metastases or other unresectable metastases who would therefore not undergo standard of care proctectomy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to metronidazole or other agents used in study.\n* Prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.\n* Concurrent treatment with disulfiram.\n* Cockayne syndrome.\n* Participants with uncontrolled intercurrent illness (Indicate clearly what type or extent).\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because metronidazole is a B2 agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with metronidazole, breastfeeding should be discontinued if the mother is treated with metronidazole. These potential risks may also apply to other agents used in this study.\n* Participants who received cytotoxic chemotherapy within the last year are excluded from this study given known associations between chemotherapy administration and alterations in the tumoral microbiome.",{"count":323,"type":21},60,[66],"To learn if adding metronidazole to standard therapy can decrease populations of Fusobacterium nucleatum (F. nucleatum) and other anaerobes (small organisms that cause infections) in participants with rectal cancer receiving neoadjuvant therapy, compared to neoadjuvant therapy alone.",[29],"2026-04-13",{"date":329,"type":46},"2026-04-16",{"date":331,"type":46},"2024-07-10",{"date":333,"type":21},"2028-10-31",{"name":221,"class":53},{"id":336,"slug":4,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100615414","NCT07292298","Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates","Inclusion Criteria:\n\n1. Provision to sign and date the consent form.\n2. Stated willingness to comply with all study procedures and be available for the duration of the study.\n3. Adults (18-100 years old)\n4. ECOG 0-3\n5. Patients with MMR-proficient low-mid rectal adenocarcinoma cT1-4 N0-2 M0 who underwent total neoadjuvant therapy who have not achieved complete response (i.e. incomplete or near-complete) in the rectal primary tumor such that surgical resection, if offered presently or in the future, would be an APR or low LAR per colorectal surgeon expert opinion and central review at University of Colorado rectal tumor board. Tumor restaging will be 4-16 weeks following completion of total neoadjuvant therapy, and no sooner than 8 weeks if patients received chemotherapy followed by chemoradiation\u002Fshort course radiation.\n6. Residual rectal disease must have its craniocaudal extent \\\u003C4 cm with thickness \\\u003C1.2 cm. Tumor must have \\\u003C50% circumferential involvement. Residual disease must be above the dentate line and not involving the anal canal.\n7. In patients with original cN1-2 disease, restaging CT and MRI after total neoadjuvant therapy must demonstrate at least near-complete response of the pelvic lymph nodes per NCCN criteria as evaluated by central review at University of Colorado rectal tumor board.\n8. Interval of time between completion of TNT and initiation of rectal brachytherapy must be between 4-16 weeks.\n9. Patients must be recovered from total neoadjuvant therapy and must not have significant rectal incontinence at time of screening.\n10. Received conventionally fractionated external beam chemoradiation between 45-56 Gy or short-course external beam radiation prescription of 25 Gy to rectal mucosa, in addition to systemic chemotherapy before or after radiation per National Comprehensive Cancer Network (NCCN) guidelines.\n11. Women of child-bearing potential must have a negative urine or serum pregnancy test within 14 days of HDR treatment.\n12. Men and women of reproductive potential who are sexually active must agree to follow instructions of contraception for the duration of the study and 6 months post-rectal brachytherapy completion.\n13. CBC at the time of screening must have platelets\\>50 10\\^9\u002FL, Hemoglobin\\>8 g\u002FdL and Absolute Neutrophil Count \\> 500 10\\^9\u002FL\n\nExclusion Criteria:\n\n1. History of ulcerative colitis or Crohn's disease.\n2. Pelvic radiotherapy given prior to rectal cancer external beam radiation.\n3. Prior colorectal surgery in which anastomotic site is at or near HDR brachytherapy target.\n\n   o Prior local excision is not an exclusion criterion.\n4. Uncontrolled intercurrent severe illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n5. Life expectancy \\\u003C3 years per provider discretion.\n6. Concurrent administration of any cytotoxic chemotherapy, immunotherapy, or other any targeted oncologic agent that would impact rectal cancer is not allowed during study protocol.\n7. If rectal cancer has been treated outside of standard total neoadjuvant therapy per NCCN guidelines, patients are ineligible for the trial. This includes if patients received external beam chemoradiation dose with prescription \\>56 Gy or short-course radiation to rectal mucosa prescription \\>30 Gy.\n8. Pregnant women.","100 Years",{"count":342,"type":21},44,[66],"Rectal cancer patients who do not achieve a complete response to standard of care chemotherapy and radiation often require surgical resection as part of curative intent therapy. This study will evaluate whether additional \"focal\" radiation delivered internally (rectal brachytherapy) can provide complete responses and thus spare the requirement for surgery.\n\nThe main questions are whether: 1) rectal brachytherapy is safe in this clinical treatment paradigm and if 2) rectal brachytherapy improves organ preservation (no need for surgery).\n\nThe trial involves an additional MRI pelvis and sigmoidoscopy with marker placement to define high-risk residual disease for radiation planning. Subsequently, 3 outpatient brachytherapy treatments are given on a weekly basis. If a patient achieves a complete response to brachytherapy, standard of care non-operative surveillance visits are conducted with study visits aligned during the first two years following brachytherapy.",[29,183],[347,348,296],"Locally Advanced Rectal Cancer","Non-metastatic Rectal Cancer","2026-04-03",{"date":48,"type":46},{"date":352,"type":21},"2026-11",{"date":354,"type":21},"2031-11",{"name":356,"class":53},"University of Colorado, Denver",3,{"id":359,"slug":4,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":83},"100217380","NCT02107105","Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer","Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer","Inclusion Criteria:\n\n* Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment\n* Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English\n\nExclusion Criteria:\n\n* Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer\n* Patient has a concurrent cancer diagnosis at the time of consent\n* Patient has recurrent disease",{"count":365,"type":21},430,"This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.",[29,32,35,116,209,210,38,211,212,213,41,368,369,370],"Stage IVA Rectal Cancer AJCC v8","Stage IVB Rectal Cancer AJCC v8","Stage IVC Rectal Cancer AJCC v8","2026-03-31",{"date":48,"type":46},{"date":374,"type":46},"2014-05-16",{"date":376,"type":21},"2030-05-31",{"name":221,"class":53},{"id":379,"slug":4,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":83},"100416471","NCT04703101","Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer","Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX","Inclusion Criteria:\n\n* Histologically confirmed rectal adenocarcinoma\n* Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI\n* No evidence of metastatic disease\n* Resectable primary lesion\n* Karnofsky performance status (KPS) \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2\n* Absolute neutrophil count (ANC) \\> 1.5 cell\u002Fmm\\^3\n* Hemoglobin (Hgb) \\> 8.0 gm\u002FdL\n* Platelets (PLT) \\> 150,000\u002Fmm\\^3\n* Total bilirubin \\\u003C or equal to 1.5 x upper limit of normal\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C or equal to three times upper limit of normal\n* If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy\n\nExclusion Criteria:\n\n* Active treatment of a separate malignancy\n* Distant metastatic disease as assessed by staging positron emission tomography (PET)\u002Fcomputed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Pregnant and\u002For breastfeeding\n* Medical\u002Fpsychological contraindication to MRI",{"count":7,"type":21},[386],"PHASE1","This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.",[389,29,35,116,209,210,38,211,212,213],"Locally Advanced Rectal Carcinoma","2026-03-25",{"date":392,"type":46},"2026-03-30",{"date":394,"type":46},"2021-02-11",{"date":396,"type":21},"2027-10-15",{"name":398,"class":53},"Jonsson Comprehensive Cancer Center",{"id":400,"slug":4,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":409,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":83},"100424547","NCT04808323","MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer","Inclusion Criteria:\n\n1. Age ≥ 18.\n2. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum.\n3. Determined on staging evaluation to be clinical stage I, II or III.\n4. No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or \"equivocal\" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This \"equivocal\" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise.\n5. Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.\n6. History\u002Fphysical examination, including collection of weight and vital signs within 45 days prior to start of treatment.\n7. MR of the rectum is mandatory for staging and follow-up.\n8. Chest CT scan within 45 days prior to study entry.\n9. Radiation treatment planning abdominal CT. A mandatory pelvic MR will be done as a simulation (SIM) (ideally with interpretation). The CT SIM will not be done with interpretation. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is mandatory.\n10. Laboratory values (CBC, Chem24) 45 days prior to treatment as follows:\n\n    1. Carcinoembryonic antigen (CEA) (any value).\n    2. Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3.\n    3. Platelets ≥50,000 cells\u002Fmm3.\n    4. Hemoglobin ≥ 8.0 g\u002Fdl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable.)\n    5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 4 x upper limit of normal.\n    6. Total bilirubin \\\u003C 2 x upper normal mg\u002FdL.\n    7. Alkaline phosphatase \\\u003C 4 x upper limit of normal.\n11. Not on hemodialysis.\n12. Ability to swallow oral medications.\n13. Patients must be determined by medical oncology to be a candidate for systemic chemotherapy.\n14. Patients must provide study-specific informed consent prior to study entry.\n15. Negative serum pregnancy test (if applicable).\n16. Women of childbearing potential and male participants who are sexually active must practice adequate contraception.\n\nExclusion Criteria:\n\n1. Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease.\n2. Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years\n3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.\n4. Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion.\n5. Severe, active comorbidity, defined as follows:\n\n   1. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last six months.\n   2. Transmural myocardial infarction within three months prior to study entry.\n   3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n   4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.\n   5. Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function.\n   6. Any unresolved intestinal obstruction.\n   7. Acquired immune deficiency syndrome (AIDS), based upon current Centers for Disease Control and Prevention (CDC) definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with required treatment medications, such as capecitabine.\n   8. Absence of any significant medical comorbidity which would preclude the consideration of major intestinal surgery.\n6. Pregnancy or women of childbearing potential and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception during the course of the study and for women three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic.\n7. Participation in another interventional clinical treatment trial while on study (observational trials are permitted).\n8. Patients taking nonprotocol-specified chemotherapy agents or immune-modulating agents for other medical conditions are not permitted to participate in this trial. Any medication questions should be reviewed by the PI.\n9. Poor functional status such that patients are not able to be positioned for radiation treatments.\n10. Gadolium allergy.\n11. If age over 60, history of hypertension, diabetes or liver transplant, and glomerular filtration rate (GFR) at enrollment is \\\u003C 30.",{"count":405,"type":21},22,[386],"This study is a prospective, open-label, phase I design.",[29],[410,411],"MR-guided radiation therapy","Rectal adenocarcinoma","2026-03-12",{"date":414,"type":46},"2026-03-16",{"date":416,"type":46},"2021-06-17",{"date":418,"type":21},"2029-01-20",{"name":420,"class":53},"Medical College of Wisconsin",{"id":422,"slug":4,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":83},"100589260","NCT06952101","A Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity","INTERPRETE: a Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity","INTERPRETE","Inclusion Criteria:\n\n* Patients aged ≥18 yrs old\n* Patients able to sign the informed consent\n* Patients with High Risk pT1 rectal adenocarcinoma endoscopically excised\n* Patients with cT2-3aN0 rectal adenocarcinoma who has complete\u002Fmajor response to EXPERIMENTAL CRT\n* Patients with cT3b4N0-1 rectal adenocarcinoma who has complete\u002Fmajor response to STANDARD CRT\n\nExclusion Criteria:\n\n* cT2-4 any NM0 who don't reach cCR or cMR after experimental\u002Fstandard CRT\n* Pregnancy",{"count":167,"type":21},[24],"A phase II, single-center, non-profit, interventional study on patients affected by rectal adenocarcinoma. Patients will be stratified into three groups based on pre-treatment clinical stage. The study investigates and may propose a comprehensive, stage-specific, multimodal approach to rectal adenocarcinoma, with a focus on organ preservation even in early stages (cT1-2N0). When organ-sparing strategies are not feasible, the approach prioritizes minimally invasive techniques (laparoscopic and robotic) to reduce the physical, psychological, and quality-of-life impact on patients.",[29,432],"Non Metastatic",[29,434,435,436],"mininvasivity","organ sparing","surgical rectal resection","2026-03-03",{"date":439,"type":46},"2026-03-05",{"date":441,"type":46},"2024-04-30",{"date":443,"type":21},"2030-12-31",{"name":445,"class":53},"Fondazione del Piemonte per l'Oncologia",{"id":447,"slug":4,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":463,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":478},"100624271","NCT07407465","Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.","Phase II Single Arm Study of Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer: the CHIMERA Study.","CHIMERA","Inclusion Criteria:\n\n* Written informed consent obtained from the patient\u002Flegal representative before performing any protocol-related procedures, including screening evaluations.\n* Patient state to comply with all the study procedures and treatments. Patients must be accessible for treatment and follow-up. Patients registered for this trial must be treated and followed at the participating Centre.\n* Age ≥ 18 years at the time of informed consent.\n* ECOG Performance Status ≤ 2.\n* Life expectancy of ≥ 3 months.\n* Have histologically documented adenocarcinoma of the colon or rectum, which is initially metastatic or unresectable locally advanced.\n* Subjects must be willing to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks (or at least 25 freshly sectioned slides) for translational analyses (sampled before 1st treatment course). If archival tissue is not available for HER2 testing or for exploratory aims, then a newly obtained baseline biopsy of an accessible tumor lesion is required before Cycle 1 Day 1 timeframe. Biopsy must contain adequate tissue for analysis; the following biopsy types are acceptable: resection, excision, punch (skin lesions only) and core needle biopsies.\n* Presence of locally determined HER2 overexpression\u002Famplification defined as IHC 3+ or 2+\u002FISH amplified on archival\u002Fnewly obtained tumor tissue, according to the American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines for gastric\u002Fgastroesophageal cancer.\n* Have RAS known status and pMMR\u002FMSS status by standard local testing.\n* Have radiographically measurable disease per RECIST v1.1.\n* Have adequate hematological, hepatic, renal, cardiac and coagulation function, as defined below, obtained ≤ 7 days prior to enrollment (Cycle 1 Day 1):\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3. (Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1).\n  * Platelet count ≥ 100000\u002Fmm3. (Platelet transfusion is not allowed within 1 week prior to C1D1)\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 5 x ULN if liver metastases are present).\n  * Serum albumin ≥ 2.5 g\u002FdL.\n  * Creatinine clearance ≥ 60 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight).\n  * Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before enrollment.\n  * International normalized ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 x ULN.\n* Have had adequate washout period from previous treatment before screening, defined as:\n\n  * ≥ 4 weeks from major surgery.\n  * ≥ 4 weeks from radiation therapy, including palliative stereotactic radiation therapy to the chest.\n  * ≥ 3 weeks from anti-cancer chemotherapy \\[immunotherapy (non-antibody-based therapy)\\], retinoid therapy, hormonal therapy.\n  * ≥ 4 weeks from antibody-based anti-cancer therapy\n  * ≥ 2 weeks or 5 half-lives (whichever is longer) from targeted agent- and small molecule-based therapy\n  * ≥ 6 weeks from nitrosureas or mitomycin C\n  * ≥ 1 week from TKIs approved for treatment of patients with non-small-cell lung cancer (baseline CT must be completed after discontinuation of TKI)\n  * \\> 2 weeks from chloroquine\u002Fhydroxychloroquine\n  * ≥ 2 weeks from cell-free and Concentrated Ascites Reinfusion Therapy (CART), peritoneal shunt or drainage of ascites, pleural or pericardial effusion.\n* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta- human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of IP. Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1. From the time of screening and must agree to continue using such precautions for 7 months after the last dose of investigational product (IP). Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n* Female participants must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study.\n* Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period, by employing protocol-recommended methods. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of randomization\u002Fenrollment, throughout the study and for 4 months after the last dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Preservation of sperm should be considered prior to enrollment in this study.\n\nExclusion Criteria:\n\n* Have previously received any systemic anticancer therapy for CRC in the metastatic\u002Flocally advanced unresectable setting or have participated in any interventional clinical trial for CRC in the metastatic\u002Flocally advanced unresectable setting. Subjects may have received prior fluoropyrimidine with or without oxaliplatin for CRC in the adjuvant or neoadjuvant setting if it was completed \\> 6 months before enrollment.\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.\n* Have previously been treated with an anti-HER2 agent and\u002For a topoisomerase I inhibitor.\n* Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medications.\n* Have substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n* Patients with a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above ULN at screening (as defined by the manufacturer) and without any myocardial-related symptoms should undergo a cardiologic consultation before enrollment to rule out MI.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening 12-lead ECG.\n* Symptomatic arterial hypertension or uncontrolled arterial hypertension, as determined by the investigator.\n* Have a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.).\n* Any autoimmune, connective tissue, or inflammatory disorders (e.g., Rheumatoid arthritis, Sjögren's, sarcoidosis etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for patients who are included in the study.\n* Prior pneumonectomy (complete).\n* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n* Have unresolved toxicities from previous anticancer therapy, defined as toxicity (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\> 2 for at least 3 months before enrollment\u002Fcycle 1 day 1 and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy such as: chemotherapy-induced neuropathy and fatigue.\n* Patients with known hypersensitivity to the study drug or to its excipients.\n* Patients with known hypersensitivity to other monoclonal antibodies.\n* Pregnant or breastfeeding female patients, or patients who are planning to become pregnant. Sexually active men not willing to use adequate contraception during whole study period.\n* Previous or concurrent malignancy within 3 years of study entry. Exceptions are adequately resected non-melanoma skin cancer, curatively treated in-situ diseases, and other solid tumors that have been curatively treated.\n* Presence of any of the following dihydropyrimidine dehydrogenase (DPYD) polymorphism, based on local laboratory testing: DPYD 2a (c.1905+1G\\>A); DPYD13 (c.1679 T\\>G); DPYD D949V (c.2846 A\\>T). French and German patients may undergo baseline uracilemia assessment as detailed below in spite of polymorphism testing.\n* Have a history of transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to enrollment (Cycle 1 Day 1).\n* Have a history of a significant bleeding event (e.g., bleeding needing medical intervention) within 6 months prior to enrollment (Cycle 1 Day 1) unless the source of bleeding has been definitively treated.\n* Have a history of GI perforation within 12 months prior to enrollment (Cycle 1 Day 1).\n* Major surgical procedure or significant traumatic injury ≤ 28 days prior to enrollment (≤ 56 days for hepatectomy, open thoracotomy or major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Prior organ transplantation, including allogenic stem-cell transplantation.\n* Known history of HIV infection.\n* Active infection including tuberculosis, hepatitis B, hepatitis C. Patients positive for hepatitis C (HCV) antibody are eligible only if HCV RNA polymerase chain reaction (PCR) is negative. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible only if meeting the following criteria:\n\n  * HBsAg negativity (for more than 6 months off anti-viral treatment).\n  * Anti-HBc positivity (IgG or total Ig).\n  * Absence of cirrhosis or fibrosis on prior imaging or biopsy.\n  * Absence of HCV co-infection and no history of HCV co-infection.\n  * Access to a local HBV expert during and after the study Patients meeting all abovementioned criteria must be closely monitored for HBV reactivation.\n* Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP\n* Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements.\n* Use of any disallowed drugs (see Section 7.5).\n\nAdditional exclusion criteria for France and Germany:\n\n* Patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (uracilemia ≥ 16 ng\u002FmL)\n* Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.",{"count":454,"type":21},42,[66],"The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic\u002Flocally advanced unresectable colorectal cancer",[458,28,29,459,460,461,462],"Colorectal Cancer","Rectal Cancer, Adenocarcinoma","Rectal Cancer, Metastatic","Colon Cancer Metastatic","Colon Cancer Adenocarcinoma",[464,465,466,270,467,468],"colorectal cancer","HER-2 positive","Trastuzumab-deruxtecan","Bevacizumab","mCRC","2026-02-15",{"date":471,"type":46},"2026-02-17",{"date":473,"type":46},"2025-10-20",{"date":475,"type":21},"2027-10-20",{"name":477,"class":53},"Gruppo Oncologico del Nord-Ovest",28,{"id":480,"slug":4,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":83},"100624525","NCT07410767","Advanced Endoscopic Resections for Rectal Neoplasms","Adoption of Advanced Endoscopic Resection Methods in the Treatment of Rectal Neoplasms","Inclusion Criteria:\n\n* Patients with rectal neoplasms treated by advanced endoscopic resection\n\nExclusion Criteria:\n\n* hybrid resection performed\n* full-thickness resection performed\n* essential procedural or outcome data were unavailable",{"count":486,"type":21},300,"This study evaluates how advanced endoscopic resection techniques affect treatment outcomes in adults with rectal cancer.\n\nRectal cancer has traditionally been treated with standard abdominal surgery. Newer endoscopic techniques allow removal of selected early tumors and may reduce treatment-related complications. However, their effectiveness and safety in tumors with deeper invasion are not yet fully established.\n\nThis multicenter retrospective observational study uses existing medical records from adults who underwent endoscopic or surgical resection of rectal tumors between 2015 and 2025. Researchers will analyze anonymized information on procedures performed and treatment outcomes to assess the safety and effectiveness of advanced endoscopic approaches.\n\nThe results of this study may help guide treatment selection and improve care for people with rectal cancer.",[183,29,184,489,490],"Rectal Neuroendocrine Neoplasm","Recurrent Rectal Adenocarcinoma","2026-02-13",{"date":493,"type":46},"2026-02-18",{"date":495,"type":21},"2026-03-01",{"date":497,"type":21},"2026-04-30",{"name":499,"class":53},"Jagiellonian University",{"id":501,"slug":4,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":83},"100609027","NCT07209215","ctDNA-Informed Management of Early-Stage Rectal Cancer","ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)","ULTIMATE","Inclusion Criteria:\n\n* Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay.\n* Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation.\n* Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation.\n* Patients ≥18 years of age at time of consent.\n* Ability to understand and willingness to sign the informed consent form (ICF).\n* Ability and stated willingness to adhere to the study visit schedule and protocol procedures\u002Frequirements.\n\nExclusion Criteria:\n\n* Prior treatment for rectal cancer, except for cohort B.\n* Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.\n* Patients on hemodialysis.\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial",{"count":167,"type":21},[66],"This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.",[29,183,511,233],"Early-stage Rectal Cancer","2026-01-15",{"date":514,"type":46},"2026-01-20",{"date":516,"type":21},"2026-03",{"date":518,"type":21},"2028-05",{"name":520,"class":53},"University of California, Davis",{"id":522,"slug":4,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":17,"minAge":175,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":543},"100619488","NCT07345273","Reporting of Tumour Deposits in Colorectal Cancer by Radiology and Pathology","RADAR","Inclusion Criteria:\n\n1. Primary adenocarcinoma of the rectum (proven by biopsy)\n2. Undergone surgical resection between 01st January 2007 to 31st December 2017 inclusive for the TNM 5 cohort\n3. Undergone surgical resection between 01st January 2022 to 31st December 2024 inclusive for the TNM 8 cohort\n\n3\\. Staging with MRI reports are available 4. Post-operative pathology report available 5. Patients aged 16 years and over\n\nExclusion Criteria:\n\n1. Synchronous metastatic tumours\n2. Under the age of 16 years\n3. MRI and\u002For pathology reports are not available",{"count":528,"type":21},225,"Recent research shows that tumour deposits-small spots of cancer found near the main bowel tumour-may give doctors important information about how aggressive the cancer is and how likely it is to come back.\n\nDoctors can find tumour deposits either:\n\n1. When looking at scans before surgery, or\n2. when examining the removed bowel tissue under the microscope after surgery.\n\nIn the past, tumour deposits were not always recorded properly. This is because older cancer-staging systems (called TNM 5) used in the UK treated these spots differently, depending on their size, and sometimes labelled them as lymph nodes even when they were not. As a result, many tumour deposits were missed in reports.\n\nSince 2018, the UK has been using an updated staging system (called TNM 8) that gives tumour deposits their own category. This means doctors are now expected to report them separately when they are found in the tissue around the bowel.\n\nThis matters because the investigators know that patients who have tumour deposits may have a higher risk of the cancer returning or spreading. Because of this, these patients might benefit from extra treatment-such as chemotherapy or radiotherapy-on top of surgery.\n\nHowever, if tumour deposits are not routinely recorded on scans or pathology reports, doctors may not realise a patient has them. This means that:\n\n1. Patients may not get the most appropriate advice about their cancer, and\n2. Patients may miss out on treatments that could help reduce the chance of the cancer returning.\n\nThis research project aims to find out two things:\n\n1. Are tumour deposits being routinely reported on scans and pathology reports for rectal cancer since the newer TNM 8 system was introduced? And\n2. Is there a link between reporting tumour deposits and another important finding called EMVI (extramural vascular invasion), which also affects cancer behaviour and treatment decisions?",[29],[29,532,533,534],"Tumour Deposits","TNM staging","Extramural Venous Invasion","2026-01-06",{"date":512,"type":46},{"date":538,"type":21},"2026-02",{"date":540,"type":21},"2026-05",{"name":542,"class":53},"Imperial College London",4,{"id":545,"slug":4,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":559,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":83},"100619075","NCT07339904","ProLARS Trial: Prospective Longitudinal Follow-up of Low Anterior Resection Syndrome (LARS) and COREFO Score After Rectum Surgery in Patients Undergoing Upfront Surgery or Different Neo-adjuvant Treatment Regimens","ProLARS","Inclusion Criteria:\n\n* 18 years or older.\n* Diagnosis of rectal cancer, discussed at the multidisciplinary consultation, with the intention to perform a sphincter preserving total mesorectal excision (TME) or partial mesorectal excision (PME), regardless of the need of neoadjuvant treatment.\n\nExclusion Criteria:\n\n* History of inflammatory bowel disease (Crohn's disease, ulcerative colitis) due to often persistent bowel complaints and therefore distorted baseline and follow-up data.\n* Dementia or intellectual disability.\n* Patients who are obstructive and in need a decompressive stoma or rectal stenting due to the lack of baseline data as they are often admitted to the hospital in an urgent setting",{"count":551,"type":21},100,[24],"OBJECTIVE Low anterior resection syndrome (LARS) is a term for functional bowel complaints occurring after low anterior resection. Symptoms can range from faecal incontinence and frequent loose stools to urgency and incomplete emptying with great impact on quality of life. Little is known about the longitudinal evolution of LARS and the impact of different schedules of neoadjuvant chemoradiotherapy combined with surgery.\n\nThe investigators aim to investigate the incidence and evolution of functional bowel complaints in function of different neoadjuvant treatment regimens, type of surgery and adjuvant therapy in patients who undergo surgery for rectal cancer. The investigators focus on following objectives: evolution of LARS- and COREFO-scores per treatment regimen and their impact on work incapacity; identification of possible risk factors potentially related to functional outcome; monitoring and treatment of LARS.\n\nMETHODS This will be a multicentre prospective interventional study. The study population will consist of adult patients with rectal cancer, regardless of any neo-adjuvant therapy. Patients will be included for 5 years with a 2 year postoperative follow-up. Interim analysis will be made after 2 years of inclusion. Patients with intellectual disability or clinical colon obstruction are excluded. Automated online questionnaires including LARS and COREFO scores, incapacity for work and defecation quality will be sent at different time points (figure 1) using REDCap.\n\nRESULTS and CONCLUSIONS Longitudinal change of LARS- and COREFO-scores will be visually summarized. Patient, disease or procedure specific risk factors will be assessed as well.\n\nLARS is proven to be the principal postoperative problem after rectal surgery. If the investigators can predict the severity of LARS (minor or major LARS), this can be extremely helpful in deciding whether to perform a sphincter-sparing resection or a rectal amputation instead. Furthermore, the investigators want to offer perspective to patients who are susceptible to a disturbed postoperative bowel function.",[29,555,556,557,558],"LARS - Low Anterior Resection Syndrome","Rectal Resection","Low Anterior Resection","Total Mesorectal Excision",[560,561,562,563,564],"LARS","Rectal resection","Total mesorectal excision","Low anterior resection","Rectal carcinoma","2026-01-05",{"date":567,"type":46},"2026-01-14",{"date":569,"type":46},"2024-08-26",{"date":571,"type":21},"2029-08",{"name":573,"class":53},"University Hospital, Antwerp",{"id":575,"slug":4,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":580,"targetDuration":4,"studyType":22,"phases":582,"briefSummary":583,"conditions":584,"keywords":590,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":599,"locationsCount":83},"100608177","NCT07198165","SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC","Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy.\n* Exclusion of patients with BRAF mutations or MSI-H status, as determined by pre-enrollment genetic testing including RAS, BRAF, and MSI analysis. RAS mutation status is permitted regardless.\n* Absence of severe intestinal obstruction symptoms and no evidence of distant metastasis confirmed by imaging examinations such as CT, MRI, or PET\u002FCT.\n* Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.\n* Age 18 to 75 years.\n* ECOG Performance Status of 0 to 1, without severe comorbid medical conditions.\n* Adequate organ function:\n\nHematopoietic: Hemoglobin ≥90 g\u002FL, Platelets ≥80 × 10\\^9\u002FL, Absolute Neutrophil Count ≥1.5 × 10\\^9\u002FL.\n\nHepatic: ALT and AST \\\u003C 2.5 × ULN. Renal: Serum Creatinine \\\u003C 1.5 × ULN.\n\n* Provision of signed and dated written informed consent.\n\nExclusion Criteria:\n\n* Patients found to have BRAF mutations or MSI-H status.\n* Patients who have previously received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer prior to enrollment.\n* History or presence of another malignancy (except for early-stage basal cell carcinoma or carcinoma in situ of the cervix) within the past 3 years, with the disease not under control.\n* Patients who are pregnant (confirmed by serum or urine β-HCG test) or breastfeeding.\n* Patients with severe cardiac, hepatic, renal, neurological, or psychiatric diseases.\n* Patients with active infections.\n* Poor overall health status, with an ECOG performance status ≥2.\n* Patients who have undergone organ transplantation requiring immunosuppressive therapy, or those requiring long-term corticosteroid treatment for autoimmune diseases.\n* Patients with comorbid conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study.\n* Known hypersensitivity to any of the study drugs.",{"count":581,"type":21},104,[66],"This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.",[183,29,585,586,74,298,587,588,589],"Rectal Cancer, Radiotherapy","Rectal Cancer Patients","Total Neoadjuvant Treatment","Targeted Therapy","Chemoradiotherapy",[591,298,74,592,589],"Rectal cancer","Targeted therapy","2025-09-27",{"date":595,"type":46},"2025-09-30",{"date":597,"type":46},"2025-09-05",{"date":443,"type":21},{"name":600,"class":53},"Ruijin Hospital",{"id":602,"slug":4,"hasResults":11,"nctId":603,"briefTitle":604,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":619},"100445483","NCT05081024","Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer","Inclusion Criteria:\n\n* Participant must provide written informed consent before any study-specific procedures or interventions are performed\n* Participants aged \\>= 18 years\n* Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:\n\n  * T3N0M0 - T4bN2M0\n\nExclusion Criteria:\n\n* Has radiologic evidence of distant metastases at the time of screening\u002Fenrollment\n* Has received prior treatment for their rectal adenocarcinoma\n* Requires or has received blood transfusion within 1 month of study enrollment",{"count":607,"type":21},50,"This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.",[29,35,116,209,210,38,211,212,213],"2025-09-24",{"date":612,"type":46},"2025-09-25",{"date":614,"type":46},"2021-09-03",{"date":616,"type":21},"2026-09-03",{"name":618,"class":53},"OHSU Knight Cancer Institute",2,{"id":621,"slug":4,"hasResults":11,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":628,"briefSummary":629,"conditions":630,"keywords":631,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":83},"100605330","NCT07161115","Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer","A Phase II Study Evaluating the Efficacy and Safety of Neoadjuvant Therapy With MRI-Guided Involve-site Short-Course Radiotherapy Combined With Immunotherapy and Chemotherapy for Locally Advanced Rectal Cancer","REFIRT","Inclusion Criteria:\n\n* Voluntarily agrees to participate and provides written informed consent\n* Age 18 to 75 years, male or female\n* Histologically confirmed rectal adenocarcinoma\n* MRI confirms that the upper margin of the tumor is ≤12 cm from the anal verge\n* ECOG performance status of 0-1\n* Clinical stage T3-T4 or N+ and circumferential resection margin (CRM) positive by imaging evaluation; lateral lymph nodes negative\n* Immunohistochemistry or genetic testing indicates pMMR or MSS status\n* Adequate organ function and bone marrow reserve\n\nExclusion Criteria:\n\n* Presence of distant metastasis\n* Prior pelvic radiotherapy\n* Chemotherapy or immunotherapy within the past 3 months\n* Refusal to undergo radical surgery for rectal cancer\n* Concurrent active malignancy other than rectal cancer\n* Positive antinuclear antibody (ANA)\n* History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis)\n* Elevated troponin above the normal range\n* Active tuberculosis\n* Positive hepatitis B surface antigen (HBsAg) or detectable HBV DNA\n* Positive for hepatitis C virus (HCV), syphilis, or HIV\n* Severe comorbid conditions (e.g., serious infection, severe bone marrow suppression, psychiatric disorder) deemed unsuitable for participation by the investigator\n* Pregnant or breastfeeding women\n* Any other contraindications to radiotherapy, chemotherapy, or immunotherapy",{"count":323,"type":21},[66],"Surgery is the primary treatment for rectal cancer. However, in patients with locally advanced disease, direct surgery often fails to achieve complete tumor resection. In such cases, neoadjuvant therapy is required to downstage the tumor before surgery. The current standard neoadjuvant approach consists of preoperative radiotherapy and then surgery. Although effective, standard radiotherapy uses large target volumes, which results in significant toxicities, increased surgical complications, and reduced patient compliance and quality of life. In addition, excessive radiation fields can compromise the intensity and timing of systemic therapy, potentially increasing the risk of distant metastasis. This may be one of the key reasons why current neoadjuvant radiotherapy mainly improves local control but has not translated into prolonged overall survival.\n\nEmerging evidence suggests that combining immunotherapy with radiotherapy may further enhance treatment efficacy. However, large radiation fields may impair the effectiveness of immunotherapy. Therefore, reducing the radiotherapy target volume may not only decrease treatment-related toxicity but also augment the immunotherapy response.\n\nThis clinical study is designed to evaluate whether reducing the radiotherapy target volume, when combined with chemotherapy and immunotherapy prior to surgery, can decrease radiotherapy-related toxicities and reduce the risk of distant metastasis, without increasing the local recurrence rate, compared with the current standard radiotherapy fields. The ultimate goal is to improve the efficacy of neoadjuvant therapy in locally advanced rectal cancer while minimizing treatment toxicity, thereby providing new strategies and evidence for preoperative management.",[29],[632,633,634,635],"rectal cancers","radiotherapy","immunotherapy","Reducing the radiation field for radiotherapy","2025-09-12",{"date":638,"type":46},"2025-09-15",{"date":640,"type":21},"2025-09-19",{"date":642,"type":21},"2030-08-31",{"name":644,"class":53},"Longhao Li",""]