New cocktail aims to outsmart deadly colorectal cancer
NCT ID NCT07506109
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of four drugs (sintilimab, ipilimumab, cetuximab, and dabrafenib) in people with a specific type of advanced colorectal cancer that has a BRAF V600E mutation and is microsatellite stable. These cancers are hard to treat and don't respond well to standard immunotherapy alone. The goal is to see if this drug mix can shrink tumors or slow the cancer's growth. About 49 adults who have not had certain prior treatments will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 49 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provided written informed consent. 2. Age ≥ 18 years. 3. Histologically or pathologically confirmed colorectal adenocarcinoma. 4. Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing. 5. Locally advanced unresectable disease or distant metastasis. 6. No prior treatment with BRAF/MEK/ERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors (ICI). 7. Presence of measurable target lesions per RECIST 1.1. 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 9. Adequate organ function, based on the following laboratory values obtained within 7 days prior to Cycle 1 Day 1: 1. Hemoglobin ≥ 9.0 g/dL. 2. Absolute neutrophil count ≥ 1,500/mm³ (≥ 1.5 × 109/L). 3. Platelet count ≥ 80,000/mm³ (≥ 80 × 109/L). 4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. 6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min. 10. Willing and able to comply with study procedures and visit schedule. Exclusion Criteria: 1. Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment. 2. Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and paracentesis/drainage). 3. 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). 4. Presence of severe comorbidities or serious medical conditions. 5. Pregnant or breastfeeding females. 6. The investigator deems the patient unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, China
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Peking union medical college hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, Tianjin Municipality, China
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West China Hospital Sichuan University
NOT_YET_RECRUITINGChengdu, Sichuan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- A 2.2 mm scope could spot cancerous tissue in minutes, not days
- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers