Can a four-drug cocktail shrink hard-to-treat colorectal cancer?

NCT ID NCT07722754

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

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  1. 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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  2. A doctor treating you

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