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Triple therapy aims to wipe out rectal tumors before surgery

NCT ID NCT07297030

Disease control Sponsor: Sun Yat-sen University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests a new approach for people with high-risk locally advanced rectal cancer. Participants will receive a short course of radiation with a boost to the tumor, combined with chemotherapy (capecitabine and oxaliplatin) and an immunotherapy drug (tislelizumab). The goal is to see if this combination can make the tumor disappear completely before any surgery, potentially improving long-term outcomes. The study plans to enroll 37 adults aged 18 to 75.

What this could mean

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

Active substance
Short-course radiotherapy with simultaneous integrated boost, capecitabine, oxaliplatin, and tislelizumab (a PD-1 inhibitor)
What this could lead to
If successful, this could offer a more effective neoadjuvant treatment for high-risk rectal cancer, potentially increasing the chance of complete tumor disappearance before surgery.
What could go wrong
This is a small, early-phase trial with only 37 participants, so results may not apply to everyone. The combination of radiation, chemotherapy, and immunotherapy may cause severe 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 37 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

May 2029

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: * Participants must voluntarily agree to join this study and sign an informed consent form. * Age at the time of signing the informed consent form must be between 18 and 75 years. * Histologically confirmed diagnosis of rectal adenocarcinoma. * High-risk locally advanced pMMR/MSS rectal cancer, categorized according to the AJCC/UICC 8th edition clinical staging and in reference to the inclusion criteria of the RAPIDO study, must meet at least one of the following conditions: cT4 stage, cN2 stage, involvement of the mesorectal fascia (MRF), or presence of laterally enlarged lymph nodes, with M0 status. * The inferior margin of the tumor must be ≤10 cm from the anal verge. * No prior anti-cancer treatment for rectal cancer (including local-regional and systemic therapy). * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1. * At least one measurable lesion according to RECIST v1.1 criteria. * Normal function of major organs without severe abnormalities in hematological, cardiovascular, pulmonary, hepatic, renal, or bone marrow function; laboratory tests must meet the following requirements: Hemoglobin (Hb) ≥ 70 g/L; White blood cell count (WBC) ≥ 3.0 × 10\^9/L; Neutrophil count (NEUT) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 100 × 10\^9/L; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Renal function (serum creatinine, sCr) level ≤ 1.5 times the upper limit of normal (ULN). Exclusion Criteria: * Evidence of distant metastasis. * Recurrent rectal cancer. * Documented allergy to the investigational drug and/or its excipients. * Contraindications to radiotherapy and/or chemotherapy. * Women who are pregnant or breastfeeding. * A history of other malignancies. * Patients who have participated in other clinical trials involving investigational drugs within the last 6 months. * Patients deemed inappropriate for inclusion in this study as determined by the investigator.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal cancer

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

  • Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

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