About this trial
A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy
Eligibility criteria
Qualifiers
Understand the experimental procedures and contents, and voluntarily sign a written informed consent;
Male or female subjects aged 18 to 75 years (inclusive) when signing the informed consent;
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;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before the first medication in the study;
Disqualifiers
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);
Patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to TCM during the screening period;
Patients with severe diabetic peripheral neuropathy (such as muscle atrophy as the main stage) and abnormal electromyography;
Patients with known allergic reactions to any component of the study drug;
Trial design
Treatments tested in this trial
- CAPEOX
- Placebo
- AC591