Can a four-drug cocktail shrink hard-to-treat colorectal cancer?
NCT ID NCT07722754
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding two extra drugs—bevacizumab and sintilimab—to the usual combination of irinotecan and cetuximab can shrink tumors in people with advanced colorectal cancer that no longer responds to irinotecan. The study enrolls 160 adults with RAS wild-type, microsatellite-stable tumors that have spread and cannot be surgically removed. The main question is whether the four-drug mix leads to more tumor shrinkage than the two-drug standard.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of bevacizumab and sintilimab added to irinotecan and cetuximab
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced colorectal cancer that has stopped responding to standard therapies.
- What could go wrong
- This is a mid-stage trial with only 160 participants, so results may not apply broadly. Adding more drugs also raises the risk of side effects.
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 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
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 75 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: * Metastatic and unresectable colorectal adenocarcinom; * RAS wild-type and MSS tumor; * Measurable lesions; * Failed to at least two lines of standard treatment containing fluoropyrimidine, irinotecan and bevacizumab; * Eastern Cooperative Oncology Group performance status 2 or less; * White blood cell≥ 3\*10\^9/L, neutrophil≥ 1.5\*10\^9/Lplatelet count≥75\*10\^9/L, hemoglobin≥60g/L; * Total serum bilirubin≤upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase ≤ 2.5\*ULN or ≤5\*ULN for subjects with liver metastasis; * Creatinine ≤ ULN or creatinine clearance ≥ 80 mL/min; * Urinary protein negative or 24-hour urinary protein ≤ 2g; * Activated partial thromboplastin time≤ULN and international normalized ratio≤1.5; * Any major surgery ≥ 4 weeks and any minor surgery ≥ 1 week and fully recovered from the procedure; * Life expectancy \> 3 months; * Provide fully informed written consent; Exclusion Criteria: * Other aggressive malignancies within 3 years (Exceptions: non-melanoma skin cancer or carcinoma-in-situ of the cervix that has been treated); * Allergy or intolerance to any of the study drugs; * Human immunodeficiency virus positive; * Concurrent anti-cancer therapy including radiation therapy, chemotherapy, targeted agents or biological agents not otherwise specified within two weeks; * Malignant bowel obstruction; * Prior treatment with PD-1 antibody; * Autoimmune diseases; * Significant bleeding events or pre-existing bleeding diathesis within 6 months (unless the source of bleeding has been resected); * Gastrointestinal perforation within 12 months; * Serious or non-healing wound, ulcer, or bone fracture; * Blood pressure \>= 160/90 mmHg after active anti-hypertensive therapy; * Arterial or venous thrombotic or embolic events within 6 months (including but not limited to transient ischemic attack, cerebrovascular accident, unstable angina or myocardial infarction); * Uncontrolled illness including active infection, symptomatic congestive heart failure, cardiac arrhythmia, respiratory failure, symptomatic pulmonary fibrosis, interstitial pneumonitis or psychiatric illness that may interfere with the conduct of the study; * Known or suspected brain or central nervous system (CNS) metastases, or carcinomatous meningitis; * Any of the following: pregnant, nursing, childbearing potential but unwilling to employ contraception.
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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
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.
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Other studies related to the condition(s) this trial covers.
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- Can a Drug-Radiation combo outsmart Treatment-Resistant colorectal cancer?
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