phase ii clinical study of ac591 in preventing oxaliplatin-induced peripheral neuropathy

Conditions: Colorectal Adenoma

Summary: a randomized, double-blind, placebo-controlled, multicenter, phase ii clinical study of ac591 in preventing oxaliplatin-induced peripheral neuropathy

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).

Eligibility criteria:
inclusion criteria: 1. understand the experimental procedures and contents, and voluntarily sign a written informed consent; 2. male or female subjects aged 18 to 75 years (inclusive) when signing the informed consent; 3. 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; 4. eastern cooperative oncology group (ecog) performance status score of 0 or 1 before the first medication in the study; 5. organ function level before the first medication in the study meets the following requirements: peripheral blood cell count: white blood cell count ≥3×109/l and neutrophil ≥1.5×109/l, platelet count ≥75×109/l, hemoglobin ≥90g/l; 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. 6. male or female subjects of fertility are required to take effective medical contraceptive measures until 3 months after the last study administration. exclusion criteria: 1. 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); 2. patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to tcm during the screening period; 3. patients with severe diabetic peripheral neuropathy (such as muscle atrophy as the main stage) and abnormal electromyography; 4. patients with known allergic reactions to any component of the study drug; 5. patients with intestinal obstruction that requires treatment; 6. active severe clinical infection (\> grade 2, national cancer institute-common adverse event evaluation criteria \[nci-ctcae v5.0\]), including active tuberculosis; 7. 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; 8. 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/or diastolic blood pressure ≥100mmhg after adequate treatment); 9. patients who need to take coumarin derivative anticoagulants (such as warfarin, phenprocoumon) regularly within 3 weeks before screening or during the study; 10. 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; 11. renal replacement therapy; 12. previous history of organ transplantation, autologous/allogeneic stem cell transplantation; 13. 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; 14. hiv infection, hepatitis b surface antigen positive (and peripheral blood hepatitis b virus deoxynucleotide hbv dna ≥ 1×104 copies/ml or ≥ 2000iu/ml), hepatitis c virus antibody positive (and peripheral blood hepatitis c virus nucleotide hcv rna ≥ 1×103 copies/ml or ≥ 200iu/ml) or active syphilis patients; 15. pregnancy (confirmed by menstrual pregnancy test) or lactation; 16. current alcohol or drug dependence; 17. suffering from known mental illness disorders that may affect trial compliance; 18. adverse events of previous anti-tumor treatment have not recovered to grade 1 (nci-ctcae v5.0) or abnormalities have no clinical significance; 19. subjects who have participated in other interventional clinical trials within 4 weeks before the first study drug; 20. the investigator believes that the patient has other factors that affect the efficacy or safety evaluation of this study