[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583069":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":45,"collaborators":18,"id":47,"slug":18,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":18,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":18,"overallStatus":71,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"fruquintinib + tislelizumab + FOLFOX","EXPERIMENTAL",[12],"Drug: fruquintinib + tislelizumab + FOLFOX",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DRUG","phase Ib: fruquintinib (3+3 dose escalation design): L1: 3 mg\u002Fd, L2: 4 mg\u002Fd, L3: 5 mg\u002Fd, qd po, D1-14, Q3W; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg\u002Fm2, D1, followed by 2400 mg\u002Fm2 as a continuous IV infusion over 46 hours,Q2W; leucovorin : 400mg\u002Fm2, I.V., D1, Q2W; Oxaliplatin: 85mg\u002Fm2, ivgtt 2h, D1, Q2W.\n\nphase II: fruquintinib: RP2D; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg\u002Fm2, D1, followed by 2400 mg\u002Fm2 as a continuous IV infusion over 46 hours,Q2W; leucovorin: 400mg\u002Fm2, I.V., D1, Q2W; Oxaliplatin: 85mg\u002Fm2, ivgtt 2h, D1, Q2W.",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Xiaohui Zhai","CONTACT","862038285497","zhaixh@mail.sysu.edu.cn",[26],{"facility":27,"status":18,"city":28,"state":29,"zip":30,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"The Sixth Affiliated Hospital of Sun Yat-sen University","Guangzhou","Guangdong","210000","China",{"type":33,"coordinates":34},"Point",[35,36],113.25,23.11667,{"lat":36,"lon":35},[39,40,43],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},{"name":41,"role":42,"phone":18,"phoneExt":18,"email":18},"Yanhong Deng","PRINCIPAL_INVESTIGATOR",{"name":21,"role":44,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":46,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100583069",false,"NCT06871527","Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer","Fruquintinib Combined With Tislelizumab and FOLFOX as First-Line Treatment For Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Open-label, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* 18-75 years old (including 18 and 75 years old);\n* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;\n* Pathologically determined gastric or gastroesophageal junction adenocarcinoma;\n* Advanced patients with radiographic confirmation of inoperable complete resection;\n* No previous anti-tumor treatment for metastatic diseases;\n* At least one measurable lesion according to RECIST version 1.1;\n* Ability to take medications orally;\n* No active bleeding;\n* Adequate organ functions:\n\nAbsolute neutrophil count ≥2×109\u002FL; Platelet ≥100×109\u002FL; Hemoglobin ≥90g\u002FL; WBC≥4×109\u002FL Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN ； Serum creatinine (Cr) ≤1.5XULN；\n\n• Have fully understood the study and voluntarily signed the informed consent;\n\nExclusion Criteria:\n\n* Patients who had received any drug in the study protocol in the last year;\n* Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;\n* HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;\n* Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;\n* Patients with massive pleural or peritoneal effusion requiring drainage;\n* Patients with severe ECG abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment;\n* Severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n* Mental disorders or central nervous system diseases or brain metastases affecting clinical treatment;\n* Patients with autoimmune diseases;\n* Patients with grade 3 or higher bleeding within 4 weeks;\n* Patients with a history of allergy to any drug, similar drug or vehicle in this study;\n* Had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy;\n* Patients with nonhealed wounds, ulcers, or fractures;\n* Patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment;\n* Pregnant or lactating women, or patients of childbearing age who refused contraception during the study period;\n* Investigators believe that the patient has any other conditions that are not suitable for participating in the study.","ALL","18 Years","75 Years",{"count":57,"type":58},44,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE1","PHASE2","This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.",[65,66,67,68,69,70],"Gastric (Stomach) Cancer","Gastric Adenocarcinoma","Fruquintinib","PD-1 Inhibitor","Tislelizumab","GEJ Adenocarcinoma","NOT_YET_RECRUITING","2025-03-11",{"date":74,"type":75},"2025-03-12","ACTUAL",{"date":77,"type":58},"2025-03-01",{"date":79,"type":58},"2028-12-31",{"name":5,"class":6},1]