最初无法切除肝转移灶的 RAS/BRAF 野生型结直肠癌患者的转换疗法

计划状态

招聘

阶段

第三阶段

允许先接受免疫治疗

没有

CRC 指导的试验

药物

mFOLFOXIRI Plus Bevacizumab, mFOLFOXIRI plus Cetuximab

标签

MSI-H/ MMRd、MSS/ MMRp
地点 位置状态
中国
Zhongshan Hospital, Fudan University
上海,上海 200032
招聘

联系方式

Jianmin Xu, MD, Ph.D.
联系
86-21-64041990 xujmin@aliyun.com
Wentao Tang, MD, Ph.D.
联系
86-21-64041990 tangwt1988@163.com

纳入标准

纳入标准

1. The primary tumor was confirmed by histology as colorectal adenocarcinoma
2. Initially unresectable liver metastases suggested by MDT
3. RAS/BRAF gene wild-type states
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy ≥ 3 months
6. Good hematological function: neutrophil ≥ 1.5x109 / L and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
7. Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization);
8. Sign the written informed consent to participate in the experiment

排除标准

排除标准:

1. Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
2. Known or suspected extrahepatic metastasis
3. Patients with known hypersensitivity to any component of the study treatment
4. Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
5. Acute or subacute intestinal obstruction
6. Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
7. Other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
8. Known drug / alcohol abuse
9. No legal capacity or limited legal capacity

NCT ID

NCT04687631

添加审判日期

2020-12-29

更新日期

2025-03-25