Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy

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