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Triple combo aims to break resistance in aggressive colorectal cancer

NCT ID NCT07809893

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing a three-part treatment for advanced colorectal cancer with a BRAF V600E mutation that has stopped responding to standard BRAF-targeted therapy. The trial combines ivonescimab, a drug that blocks two proteins involved in tumor growth and immune evasion, with intensive chemotherapy (mFOLFOXIRI) and celecoxib, an anti-inflammatory drug. About 45 adults will receive the combination to see whether it shrinks tumors and how well it is tolerated.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivonescimab combined with mFOLFOXIRI chemotherapy and celecoxib
What this could lead to
If it works, this combination could offer a new option for people whose BRAF-mutant colorectal cancer has stopped responding to standard targeted therapy.
What could go wrong
This is a small phase 2 trial with 45 participants, so any benefit may not hold up in larger studies. The drug combination is intensive and may cause significant 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 45 people

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

Started

Aug 2026

Expected to finish

Jun 2028

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 70 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: 1. Signed the informed consent form voluntarily. 2. Aged 18-70. 3. Colorectal adenocarcinoma with definite histological evidence, with evidence of distant metastasis; 4. Diagnosed with colon or rectal adenocarcinoma, with evidence of distant metastasis; 5. Genetic testing indicates a BRAF V600E mutation; 6. Previously received first-line treatment including FOLFOX/CAPOX or FOLFIRI/CAPIRI and experienced disease progression or intolerance. Among them, patients who used oxaliplatin in adjuvant therapy should have experienced disease progression within 12 months after completing adjuvant therapy; Previously received anti-BRAF V600E targeted therapy and failed, including but not limited to vemurafenib, dabrafenib, and encorafenib; 7. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. 8. Adequate organ function based on the following laboratory test values obtained within 7 days prior to treatment: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, serum total bilirubin ≤1.5× upper limit of normal value (UNL), aspartate transferase ≤2.5×UNL, alanine transferase ≤2.5×UNL, serum creatinine ≤2.5×UNL; 9. Female subjects must be either postmenopausal for at least 1 year, have undergone surgical sterilization at least 6 weeks prior, or must agree to use appropriate contraceptive measures; 10. Male subjects must agree to use appropriate contraceptive measures to prevent their partners from becoming pregnant; 11. Willing and able to comply with research protocols and visit plans. Exclusion Criteria: 1. Prior to enrollment, ctDNA testing shows known KRAS mutation, NRAS mutation, or ERBB2 gene amplification; tumor tissue testing shows mismatch repair gene deficiency or high microsatellite instability, KRAS mutation, NRAS mutation, or ERBB2 gene amplification; 2. Presence of intestinal obstruction, active bleeding, or intestinal perforation requiring emergency intervention; 3. Underwent major surgery or severe trauma in the previous 4 weeks; 4. Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within 12 months prior to study participation; 5. Occurrence of thrombotic or embolic events within the past 6 months; 6. New York Heart Association (NYHA) class II or higher congestive heart failure; 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis; 8. Any active, known, or suspected autoimmune disease. 9. Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease; 10. Any unresolved treatment-related adverse events of grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (excluding peripheral neuropathy, anemia, hair loss, and skin pigmentation); 11. Previous treatment with programmed cell death protein-1 (PD-1) and its ligand (PD-L1) inhibitors or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies; 12. Known or suspected history of allergy to any of the related drugs used in the study; 13. Pregnant or breastfeeding women.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Gastrointestinal Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510655, China

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