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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong New Time Pharmaceutical Co., LTD

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

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

This trial has no locations