Status:
RECRUITING
A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
BRAF V600E
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 pr...
Eligibility Criteria
Inclusion Criteria:
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Provided written informed consent.
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Age ≥ 18 years.
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Histologically or pathologically confirmed colorectal adenocarcinoma.
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Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.
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Locally advanced unresectable disease or distant metastasis.
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No prior treatment with BRAF/MEK/ERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors (ICI).
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Presence of measurable target lesions per RECIST 1.1.
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
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Adequate organ function, based on the following laboratory values obtained within 7 days prior to Cycle 1 Day 1:
- Hemoglobin ≥ 9.0 g/dL.
- Absolute neutrophil count ≥ 1,500/mm³ (≥ 1.5 × 109/L).
- Platelet count ≥ 80,000/mm³ (≥ 80 × 109/L).
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min.
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Willing and able to comply with study procedures and visit schedule.
Exclusion Criteria:
- Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment.
- Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and paracentesis/drainage).
- Multiple primary malignancies (exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer that has been in complete remission for at least 3 years).
- Presence of severe comorbidities or serious medical conditions.
- Pregnant or breastfeeding females.
- The investigator deems the patient unsuitable for participation in this study.
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT07506109
Start Date
March 1 2026
End Date
June 1 2028
Last Update
April 7 2026
Active Locations (4)
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1
Peking union medical college hospital
Beijing, Beijing Municipality, China
2
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
3
West China Hospital Sichuan University
Chengdu, Sichuan, China
4
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China