[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571645":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":27,"responsibleParty":42,"collaborators":27,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":27,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":27,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":27,"overallStatus":63,"whyStopped":27,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":27},{"fullName":5,"class":6},"Shandong New Time Pharmaceutical Co., LTD","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"AC591+CAPEOX","EXPERIMENTAL","AC591 granules (3 times a day) + CAPEOX chemotherapy",[13,14],"Drug: CAPEOX","Drug: AC591",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo+CAPEOX","PLACEBO_COMPARATOR","Placebo (3 times a day) + CAPEOX chemotherapy",[13,20],"Drug: Placebo",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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.",[9,16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Placebo","Placebo：3 times a day (daily), taken with boiled water.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"AC591","AC591 : 3 times a day (daily), taken with boiled water.",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Zhang jian xiang","CONTACT","0539-8330397","jianxiangzhang@126.com",{"type":43,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100571645","phase-2-phase-ii-clinical-study-of-ac591-in-preventing-oxaliplatin-induced-peripheral-neuropathy-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":55,"type":56},120,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy",[62],"Colorectal Adenoma","NOT_YET_RECRUITING","2024-12-03",{"date":66,"type":67},"2024-12-09","ACTUAL",{"date":69,"type":56},"2024-12",{"date":71,"type":56},"2026-12",{"name":5,"class":6}]