Triple therapy aims to shrink rectal tumors without surgery
NCT ID NCT07154316
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
5 sites. The list below names each one and where it is.
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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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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
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Anyang Tumor Hospital
RECRUITINGAnyang, Henan, 455100, China
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, China
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Fujian Provincial Cancer Hospital
RECRUITINGFuzhou, Fujian, 350000, China
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The First Affiliated Hospital of Shandong First Medical University
RECRUITINGJinan, Shandong, 250014, China
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Yunnan Cancer Hospital
RECRUITINGKunming, 650118, China
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- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
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