Condition: BRAF V600E · Colorectal Cancer · Sintilimab · Sponsor: Tianjin Medical University Cancer Institute and Hospital
Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall survival (OS) of only 11 months for standard chemotherapy. Most BRAF V600E-mutant mCRC are microsatellite stable (MSS) and do not benefit from single-agent PD-1/PD-L1 inhibition. Preclinical and clinical evidence indicates that BRAF inhibition in combination with EGFR blockade can induce DNA damage, trigger a deficient mismatch repair (dMMR) phenotype, and increase tumor mutational burden (TMB), thereby sensitizing MSS tumors to immune checkpoint inhibition. This provides a strong rationale for combining BRAF/EGFR inhibitors with anti-PD-1 and anti-CTLA-4 immunotherapy. This is a single-arm, open-label, Phase II clinical trial. The primary objective is to evaluate the efficacy and safety of the triplet combination of sintilimab (anti-PD-1), ipilimumab N01 (anti-CTLA-4), cetuximab (anti-EGFR), and dabrafenib (BRAF inhibitor) in patients with MSS, BRAF V600E-mutant mCRC.
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| Peking union medical college hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, China | Not Yet Recruiting |
| West China Hospital Sichuan University | Chengdu, Sichuan, China | Not Yet Recruiting |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin, Tianjin Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07506109