Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Triple therapy aims to shrink rectal tumors without surgery

NCT ID NCT07154316

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase II trial tests whether adding immunotherapy and a COX-2 inhibitor to standard chemoradiotherapy can improve complete remission rates in people with locally advanced rectal cancer that is microsatellite stable (MSS). About 138 participants will receive either long-course or short-course radiation plus the drug combo. The goal is to see if the tumor disappears completely, potentially allowing patients to avoid surgery and keep their rectum.

What this could mean

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

Active substance
capecitabine, oxaliplatin, serplulimab, celecoxib, radiation therapy
What this could lead to
If successful, this combination could offer a more effective, organ-sparing treatment for a common type of rectal cancer, potentially avoiding permanent colostomy.
What could go wrong
This is a mid-stage trial with only 138 participants, so results may not apply to all patients. Adding multiple drugs also raises the risk of serious 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 138 people

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

Started

Aug 2025

Expected to finish

Dec 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 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, regardless of gender. * Pathologically confirmed rectal adenocarcinoma. * Tumor located ≤10 cm from the anal verge. * Baseline stage T3-4 and/or N+ (locally advanced disease). * No evidence of distant metastasis. * Microsatellite stability (MSS) or proficient mismatch repair (pMMR). * Karnofsky Performance Status (KPS) ≥70. * No prior chemotherapy or any other anticancer therapy before enrollment. * No prior immunotherapy. * Able to comply with study protocol requirements throughout the study period. * Signed written informed consent obtained prior to study participation. Exclusion Criteria: * Pregnant or lactating women. * Individuals with a history of other malignant diseases within the past 5 years, excluding cured skin cancer and cervical carcinoma in situ. * Individuals with a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the clinical severity (as judged by the investigator) may impair the ability to sign the informed consent form or affect compliance with oral medication. * Clinically significant (i.e., active) heart disease, including symptomatic coronary heart disease, congestive heart failure of New York Heart Association (NYHA) class II or worse, severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the past 12 months. * Individuals requiring immunosuppressive therapy for organ transplantation and those on long-term corticosteroid therapy. * Individuals with autoimmune diseases. * Individuals with severe, uncontrolled, recurrent infections or other severe, uncontrolled concurrent diseases. * Baseline blood routine and biochemical parameters not meeting the following criteria: hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelets ≥100×10⁹/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN); alkaline phosphatase (ALP) ≤2.5×ULN; serum total bilirubin \<1.5×ULN; serum creatinine \<1×ULN; serum albumin ≥30 g/L. * Individuals with known dihydropyrimidine dehydrogenase (DPD) deficiency. Individuals with a history of hypersensitivity to any component of the study medications.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    5 sites. 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

  • Anyang Tumor Hospital

    RECRUITING

    Anyang, Henan, 455100, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, China

  • Fujian Provincial Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350000, China

  • The First Affiliated Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250014, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, 650118, China

More trials for these conditions

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