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New cocktail of drugs aims to shrink Hard-to-Treat abdominal tumors

NCT ID NCT07268677

Disease control Sponsor: Guoxiang Cai 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether adding pirfenidone and sintilimab to standard chemotherapy can shrink tumors in 30 people with colorectal cancer that has spread to the lining of the abdomen. Participants will receive the drug combination before any other treatment. The study will first check if enough tumors respond; if too few do, the trial will stop early.

What this could mean

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

Active substance
pirfenidone, sintilimab, oxaliplatin, capecitabine
What this could lead to
If this combination works, it could offer a new treatment option for people with colorectal cancer that has spread to the lining of the abdomen, potentially shrinking tumors before surgery.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The drug combination may cause side effects, and there is no guarantee it will be more effective than standard chemotherapy alone.

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 30 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Feb 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: 1. Age between 18 and 75 years; 2. Radiologically (CT/MRI/PET-CT/FAPI-PET) or pathologically confirmed peritoneal metastasis from colorectal cancer; 3. Planned to receive first-line chemotherapy; 4. ECOG performance status of 0-1; 5. Adequate hematologic, hepatic, and renal function: 1. Neutrophil count ≥ 1.5 × 10⁹/L 2. Platelet count ≥ 100 × 10⁹/L 3. Hemoglobin ≥ 8.0 g/dL 4. Creatinine clearance \> 30 mL/min 5. For patients without liver metastasis: AST and ALT ≤ 2.5 × upper limit of normal (ULN) 6. Total bilirubin ≤ 2 × ULN 7. APTT and PT ≤ 1.5 × ULN Exclusion Criteria: 1. Individuals with a tendency to bleed, hereditary bleeding disorders, or evidence of coagulation abnormalities; 2. Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception; 3. Expected survival ≤ 3 months; 4. Participation in another investigational drug trial within the past 4 weeks; 5. Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or immune checkpoint pathways); 6. Uncontrolled neurological or psychiatric disorders that may affect compliance or the ability to report treatment responses; 7. Known allergy to any study drug.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm peritoneal carcinomatosis

As listed by the trial registrant

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

Colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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.

    Open the record ↗

  2. 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.

More trials for these conditions

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