Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy (NCT06722950) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy
120 participantsStarted 2024-12
Plain-language summary
A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Organ function level before the first medication in the study meets the following requirements:
. Male or female subjects of fertility are required to take effective medical contraceptive measures until 3 months after the last study administration.
. Patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to TCM during the screening period;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool
Timeframe: At the end of Cycle 4 （each cycle is 21 days）
. 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;
. Patients with intestinal obstruction that requires treatment;
. Active severe clinical infection (\> grade 2, National Cancer Institute-Common Adverse Event Evaluation Criteria \[NCI-CTCAE V5.0\]), including active tuberculosis;
. 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;
. 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);