[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571645":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":47,"studyPopulation":11,"armGroups":48,"interventions":62,"overallOfficials":11,"centralContacts":76,"locations":11,"responsibleParty":82,"collaborators":11,"id":84,"slug":11,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":11,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":11,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":11,"overallStatus":102,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":11},{"fullName":5,"class":6},"Shandong New Time Pharmaceutical Co., LTD","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool",null,"At the end of Cycle 4 （each cycle is 21 days）",[14,16,19,21,24,26,28,30,32,34],{"measure":10,"description":11,"timeFrame":15},"At the end of Cycle 8（each cycle is 21 days）",{"measure":17,"description":11,"timeFrame":18},"The time of onset of grade 1-3 oxaliplatin-induced peripheral neuropathy assessed by the Levi rating tool for oxaliplatin","At the end of Cycle 4 and 8（each cycle is 21 days）",{"measure":20,"description":11,"timeFrame":18},"The incidence of NCI-CTCAE V5.0 ≥ grade 2 neurotoxicity in subjects during CAPEOX chemotherapy",{"measure":22,"description":11,"timeFrame":23},"The change in the EORTC-QLQ-CIPN20 score of subjects during CAPEOX chemotherapy from baseline","at the end of each cycle（each cycle is 21 days）",{"measure":25,"description":11,"timeFrame":18},"The change in the EORTCQLQ-C30 score of subjects during CAPEOX chemotherapy from baseline",{"measure":27,"description":11,"timeFrame":18},"The proportion of subjects who used analgesics due to peripheral neuropathy caused by CAPEOX chemotherapy",{"measure":29,"description":11,"timeFrame":18},"The proportion of subjects who developed acute peripheral neuropathy within 3 days after the first CAPEOX chemotherapy",{"measure":31,"description":11,"timeFrame":18},"The average cumulative dose of oxaliplatin received by the subjects during CAPEOX chemotherapy",{"measure":33,"description":11,"timeFrame":18},"The incidence of gastrointestinal adverse reactions in the subjects during CAPEOX chemotherapy",{"measure":35,"description":11,"timeFrame":18},"The proportion of subjects who did not experience neurotoxicity as assessed by the Levi rating tool dedicated to oxaliplatin",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":41,"maskingDescription":11,"whoMasked":42},"QUADRUPLE",[43,44,45,46],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This multicenter, randomized, double-blind, placebo-controlled trial aims to explore the effectiveness of AC591 particles in preventing oxaliplatin-induced peripheral neuropathy. Patients with colorectal adenocarcinoma who are prepared to receive CAPEOX (capecitabine tablets + oxaliplatin injection) postoperative adjuvant chemotherapy within 3 weeks to 2 months after surgery will be randomized in a 1:1 ratio. The subjects will be stratified based on the chemotherapy cycles they are prepared to receive CAPEOX (4 cycles vs 8 cycles).",[49,56],{"label":50,"type":51,"description":52,"interventionNames":53},"AC591+CAPEOX","EXPERIMENTAL","AC591 granules (3 times a day) + CAPEOX chemotherapy",[54,55],"Drug: CAPEOX","Drug: AC591",{"label":57,"type":58,"description":59,"interventionNames":60},"Placebo+CAPEOX","PLACEBO_COMPARATOR","Placebo (3 times a day) + CAPEOX chemotherapy",[54,61],"Drug: Placebo",[63,68,72],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":11},"DRUG","CAPEOX","CAPEOX: 130mg\u002Fm2 of oxaliplatin (D1, central intravenous drip for 2h (time window + 20min)), 1000mg\u002Fm2 of capecitabine tablets each time, orally, twice a day (D1-D14, morning and evening); repeat the CAPEOX chemotherapy regimen every 3 weeks.",[50,57],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":11},"Placebo","Placebo：3 times a day (daily), taken with boiled water.",[57],{"type":64,"name":73,"description":74,"armGroupLabels":75,"otherNames":11},"AC591","AC591 : 3 times a day (daily), taken with boiled water.",[50],[77],{"name":78,"role":79,"phone":80,"phoneExt":11,"email":81},"Zhang jian xiang","CONTACT","0539-8330397","jianxiangzhang@126.com",{"type":83,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100571645",false,"NCT06722950","Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy","A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy","Inclusion Criteria:\n\n1. Understand the experimental procedures and contents, and voluntarily sign a written informed consent;\n2. Male or female subjects aged 18 to 75 years (inclusive) when signing the informed consent;\n3. Patients with histologically confirmed colorectal adenocarcinoma. Prepare to receive CAPEOX postoperative adjuvant chemotherapy within 3 weeks to 2 months after surgery, and have never used oxaliplatin;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before the first medication in the study;\n5. Organ function level before the first medication in the study meets the following requirements:\n\n   Peripheral blood cell count: white blood cell count ≥3×109\u002FL and neutrophil ≥1.5×109\u002FL, platelet count ≥75×109\u002FL, hemoglobin ≥90g\u002FL; Liver function: total bilirubin ≤1.5 times the upper limit of normal reference value; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal reference value; Renal function: serum creatinine ≤1.5 times the upper limit of normal reference value.\n6. Male or female subjects of fertility are required to take effective medical contraceptive measures until 3 months after the last study administration.\n\nExclusion Criteria:\n\n1. known neurodegenerative disease (e.g., Parkinson's disease, Alzheimer's disease, Huntington's disease) or neuromuscular disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis, poliomyelitis, hereditary neuromuscular disease);\n2. Patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to TCM during the screening period;\n3. Patients with severe diabetic peripheral neuropathy (such as muscle atrophy as the main stage) and abnormal electromyography;\n4. Patients with known allergic reactions to any component of the study drug;\n5. Patients with intestinal obstruction that requires treatment;\n6. Active severe clinical infection (\\> grade 2, National Cancer Institute-Common Adverse Event Evaluation Criteria \\[NCI-CTCAE V5.0\\]), including active tuberculosis;\n7. Uncontrolled diabetes, severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease, but excluding recovered radiation pneumonia), liver failure;\n8. Clinically significant cardiovascular disease, New York Heart Association \\[NYHA\\] grade III-IV congestive heart failure, unstable angina, myocardial infarction, etc. within 6 months before the first dose. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg after adequate treatment);\n9. Patients who need to take coumarin derivative anticoagulants (such as warfarin, phenprocoumon) regularly within 3 weeks before screening or during the study;\n10. Patients who have used drugs that interfere with the evaluation of neuropathic pain (such as antidepressants, antiepileptic drugs) within 2 weeks before the first dose;\n11. Renal replacement therapy;\n12. Previous history of organ transplantation, autologous\u002Fallogeneic stem cell transplantation;\n13. History of other malignant tumors except colorectal cancer in the past 5 years. However, cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or early papillary thyroid carcinoma are excluded;\n14. HIV infection, hepatitis B surface antigen positive (and peripheral blood hepatitis B virus deoxynucleotide HBV DNA ≥ 1×104 copies\u002FmL or ≥ 2000IU\u002FmL), hepatitis C virus antibody positive (and peripheral blood hepatitis C virus nucleotide HCV RNA ≥ 1×103 copies\u002Fml or ≥ 200IU\u002FmL) or active syphilis patients;\n15. Pregnancy (confirmed by menstrual pregnancy test) or lactation;\n16. Current alcohol or drug dependence;\n17. Suffering from known mental illness disorders that may affect trial compliance;\n18. Adverse events of previous anti-tumor treatment have not recovered to grade 1 (NCI-CTCAE V5.0) or abnormalities have no clinical significance;\n19. Subjects who have participated in other interventional clinical trials within 4 weeks before the first study drug;\n20. The investigator believes that the patient has other factors that affect the efficacy or safety evaluation of this study","ALL","18 Years","75 Years",{"count":94,"type":95},120,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy",[101],"Colorectal Adenoma","NOT_YET_RECRUITING","2024-12-03",{"date":105,"type":106},"2024-12-09","ACTUAL",{"date":108,"type":95},"2024-12",{"date":110,"type":95},"2026-12",{"name":5,"class":6}]