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Triple therapy aims to turn inoperable bowel cancer into surgical candidates

NCT ID NCT07446465

Disease control Sponsor: Ye Xu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining chemotherapy (FOLFOX), a targeted drug (fruquintinib), and an immunotherapy (serplulimab) can shrink advanced colorectal cancer enough to allow surgery. About 42 adults with a specific genetic type (pMMR/MSS) who have not had prior treatment will receive the combination. The goal is to see if more patients can become eligible for surgery and how well the tumors respond.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 42 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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: * Age 18-75 years; * Histologically confirmed adenocarcinoma of colorectal cancer, initially unresectable locally advanced or metastatic/recurrent disease; * Expected survival ≥12 weeks; * No prior systemic antitumor therapy for colorectal cancer; * Confirmed pMMR by IHC or MSS/MSI-L by PCR or NGS; * ECOG PS 0-1; * At least one measurable lesion per RECIST v1.1; * Adequate organ and bone marrow function; * Controlled viral hepatitis status as specified; * Signed written informed consent. Exclusion Criteria: * Prior immune checkpoint inhibitor therapy; * CNS or leptomeningeal metastases; * Uncontrolled cardiovascular disease or hypertension; * Active autoimmune disease requiring systemic therapy; * Active infection including tuberculosis; * Recent major surgery; * Pregnancy or lactation; * Any condition deemed by investigators to compromise safety or study compliance.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer (locally advanced or metastatic) Colorectal cancer microsatellite stable (MSS)

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

  • Fudan University Shanghai Cancer Center

    Shanghai, Xuhui, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.