NCT05022030招募中2 期
First-line Treatment of mCapOX Plus Cetuximab Versus mFOLFOX6 Plus Cetuximab for Metastatic Left-sided CRC Patients With Wild-type RAS/BRAF Genes: a Multicenter, Randomised, Phase 2 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS) rate at 9 months
研究概览
简要总结
This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes.
详细描述
The patients, who meet the inclusion criteria and have signed the informed consent, will be randomly assigned (1:1 ratio) to receive mCapOX plus cetuximab regimen (arm A) and mFOLFOX6 plus cetuximab regimen (arm B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent and can understand and comply with the requirements of the study;
- •Men and women ≥ 18 years of age;
- •Patients with histologically or cytologically confirmed metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes;
- •Presence of at least one evaluable lesion, as defined in RECIST Version 1.1;
- •With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
- •No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy;
- •According to the imaging findings and surgical assessment of initial unresectable, synchronous metastatic colorectal cancer, no serious complications of the primary tumor (obstruction, perforation, massive hemorrhage that cannot be treated in internal medicine, etc.) ;
- •Life expectancy of longer than 3 months ( clinical assessment);
- •Requirements for lab indicators neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, hemoglobin ≥ 8 g/dL, total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH < 1500 U/L; creatinine clearance (calculated according to Cockcroft and Gault formula) > 50 mL/min or serum creatinine ≤ 1.5 × UNL;
排除标准
- •Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.
- •Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
- •Hypersensitivity to any therapeutic agent.
- •Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study;
- •Patients who have failed one or more palliative chemotherapy regimens;
- •Patients with uncontrolled hepatitis B virus
- •Peripheral neuropathy ≥ CTC grade 2;
- •Neurological or psychiatric disorders affecting cognitive performance;
- •Patients with central nervous system metastasis could not be controlled with radiotherapy;
- •Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation
- •Uncontrolled concomitant diseases within 6 months before the study, including unstable angina, acute myocardial infarction, cerebrovascular accident, etc.;
- •Pregnant or lactating patients, or those of childbearing potential who do not take adequate contraceptive measures;
- •History of other malignancies, but no disease-free survival longer than 5 years;
- •Patients concurrently receiving other anti-tumor treatment or participating in other interventional clinical trials;
- •Patients who are unable to comply with this study for psychological, family or social reasons.
- •Patients with other serious diseases that the investigator considers not suitable.
研究组 & 干预措施
Arm A
Experimental
mCapOX (capecitabine+oxaliplatin) plus cetuximab
干预措施: mCapOX plus cetuximab (Drug)
Arm B
Active Comparator
mFOLFOX6 (fluorouracil+leucovorin+oxaliplatin) plus cetuximab
干预措施: mFOLFOX6 plus cetuximab (Drug)
结局指标
主要结局
Progression free survival (PFS) rate at 9 months
时间窗: 9 months
PFS rate at 9 months is defined as the proportion of patients without PD or death at 9 months after randomization.
次要结局
- Adverse event rate(3 years)
- Progression free survival(up to 3 years)
- Disease control rate(6 months)
- Overall survival(up to 4 years)
- Objective response rate(6 months)
研究者
研究点 (1)
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