HLX208(BRAF V600E 抑制剂)联合西妥昔单抗治疗一线治疗后出现 BRAF V600E 突变的转移性结直肠癌 (mCRC) 的疗效观察

计划状态

活跃,非招募

阶段

第二阶段

允许先接受免疫治疗

CRC 指导的试验

药物

Cetuximab Injection [Erbitux], HLX208

标签

MSS/ MMRp

评论

For BRAF mutant CRC, after failure of first line treatment. Targeted therapy.

Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor medication used for the treatment of metastatic colorectal cancer (and head and neck cancer). It is mainly used in KRAS wild type metastatic CRC.

HLX208 – trial medication that is a BRAF V600E Inhibitor

地点 位置状态
中国
Fudan University Affiliated Oncology Hospital
上海
活跃,非招募

纳入标准

纳入标准

Age>=18Y
Good Organ Function
Expected survival time ≥ 3 months
Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment
ECOG score 0-1;

排除标准

排除标准:

arm 1 : Previous treatment with BRAF inhibitors or MEK inhibitors
Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
Active clinical severe infection;
A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

NCT ID

NCT04984369

添加审判日期

2021-07-30

更新日期

2023-08-21