New drug cocktail aims to fight metastatic colorectal cancer
NCT ID NCT06882915
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a combination of three drugs—TAS-102, bevacizumab, and serplulimab—in 20 people with metastatic colorectal cancer who have already had surgery to remove tumors. The goal is to see if the combination is safe and can delay cancer progression. Participants must have failed standard treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trifluridine/tipiracil (TAS-102) combined with bevacizumab and serplulimab
- What this could lead to
- If this works, it could offer a new treatment option for people with metastatic colorectal cancer who have not responded to standard therapies, potentially extending survival.
- What could go wrong
- This is a very early Phase 1 trial with only 20 people, so results may not apply broadly. The combination may cause side effects or fail to improve outcomes.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
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 to 80 years
- 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. Patients who had undergone cytoreductive surgery (CC0-1) for colorectal cancer with peritoneal metastases; 2. Patients with extra-peritoneal metastatic lesions that were unlikely to affect prognosis in the short term; 3. Patients who had failed standard therapies (disease progression or intolerance to oxaliplatin, irinotecan, fluorouracil, or other chemotherapeutic agents) or for whom no effective treatment options were available; 4. Patients with histologically and radiologically confirmed peritoneal metastasis from colorectal cancer, with microsatellite stable (MSS) status as determined by genetic testing; 5. Age ≥ 18 years at the time of informed consent; 6. Estimated life expectancy \> 6 months; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8. Adequate function of major organs (cardiac, hepatic, and renal); 9. Adequate hematological parameters: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, white blood cell count (WBC) ≥ 3.0 × 10⁹/L, hemoglobin ≥ 10 g/dL, and platelet count ≥ 100 × 10⁹/L; 10. Adequate biochemical parameters: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; serum creatinine and blood urea nitrogen (BUN) ≤ 1.5 × ULN; 11. Ability to comply with the study protocol and follow-up procedures. Exclusion Criteria: 1. Refusal to provide informed consent; 2. Currently participating in an interventional clinical study, or having received other investigational drugs or devices within 4 weeks prior to enrollment; 3. Concurrent malignancy, except for malignancies that have been clinically cured; 4. Other severe diseases that, in the investigator's judgment, may affect follow-up compliance or short-term survival; 5. Known hypersensitivity to any component of TAS-102, bevacizumab, or serplulimab; 6. Uncontrolled brain metastases; 7. Active autoimmune disease; 8. Pregnant or lactating women; 9. History of psychiatric disorders; 10. Uncontrolled comorbidities including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, severe coronary artery disease, or cerebrovascular disease, or any other condition deemed by the investigator to render the patient ineligible for enrollment; 11. Any other condition that the investigator considers unsuitable for enrollment.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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