NCT06722950尚未招募2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool
研究概览
简要总结
A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
- •Male or female subjects of fertility are required to take effective medical contraceptive measures until 3 months after the last study administration.
排除标准
- •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;
- •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);
- •Patients who need to take coumarin derivative anticoagulants (such as warfarin, phenprocoumon) regularly within 3 weeks before screening or during the study;
- •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;
- •Renal replacement therapy;
- •Previous history of organ transplantation, autologous/allogeneic stem cell transplantation;
- •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;
- •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;
- •Pregnancy (confirmed by menstrual pregnancy test) or lactation;
- •Current alcohol or drug dependence;
- •Suffering from known mental illness disorders that may affect trial compliance;
- •Adverse events of previous anti-tumor treatment have not recovered to grade 1 (NCI-CTCAE V5.0) or abnormalities have no clinical significance;
- •Subjects who have participated in other interventional clinical trials within 4 weeks before the first study drug;
- •The investigator believes that the patient has other factors that affect the efficacy or safety evaluation of this study
研究组 & 干预措施
AC591+CAPEOX
Experimental
AC591 granules (3 times a day) + CAPEOX chemotherapy
干预措施: CAPEOX (Drug)
AC591+CAPEOX
Experimental
AC591 granules (3 times a day) + CAPEOX chemotherapy
干预措施: AC591 (Drug)
Placebo+CAPEOX
Placebo Comparator
Placebo (3 times a day) + CAPEOX chemotherapy
干预措施: CAPEOX (Drug)
Placebo+CAPEOX
Placebo Comparator
Placebo (3 times a day) + CAPEOX chemotherapy
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool
时间窗: At the end of Cycle 4 （each cycle is 21 days）
次要结局
- Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool(At the end of Cycle 8（each cycle is 21 days）)
- The time of onset of grade 1-3 oxaliplatin-induced peripheral neuropathy assessed by the Levi rating tool for oxaliplatin(At the end of Cycle 4 and 8（each cycle is 21 days）)
- The incidence of NCI-CTCAE V5.0 ≥ grade 2 neurotoxicity in subjects during CAPEOX chemotherapy(At the end of Cycle 4 and 8（each cycle is 21 days）)
- The change in the EORTC-QLQ-CIPN20 score of subjects during CAPEOX chemotherapy from baseline(at the end of each cycle（each cycle is 21 days）)
- The change in the EORTCQLQ-C30 score of subjects during CAPEOX chemotherapy from baseline(At the end of Cycle 4 and 8（each cycle is 21 days）)
- The proportion of subjects who used analgesics due to peripheral neuropathy caused by CAPEOX chemotherapy(At the end of Cycle 4 and 8（each cycle is 21 days）)
- The proportion of subjects who developed acute peripheral neuropathy within 3 days after the first CAPEOX chemotherapy(At the end of Cycle 4 and 8（each cycle is 21 days）)
- The average cumulative dose of oxaliplatin received by the subjects during CAPEOX chemotherapy(At the end of Cycle 4 and 8（each cycle is 21 days）)
- The incidence of gastrointestinal adverse reactions in the subjects during CAPEOX chemotherapy(At the end of Cycle 4 and 8（each cycle is 21 days）)
- The proportion of subjects who did not experience neurotoxicity as assessed by the Levi rating tool dedicated to oxaliplatin(At the end of Cycle 4 and 8（each cycle is 21 days）)
研究者
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