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New combo therapy aims to shrink rectal tumors with fewer side effects

NCT ID NCT07161115

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase 2 trial tests a new approach for locally advanced rectal cancer: using MRI-guided, reduced-field short-course radiotherapy together with immunotherapy and chemotherapy before surgery. The goal is to shrink the tumor effectively while causing fewer side effects than standard large-field radiation. The study will enroll 60 adults with rectal adenocarcinoma to see if this combination improves local control and reduces distant spread.

What this could mean

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

Active substance
Reduced-field short-course radiotherapy combined with immunotherapy (likely a PD-1/PD-L1 inhibitor) and chemotherapy (XELOX regimen)
What this could lead to
If successful, this approach could offer a less toxic, more effective neoadjuvant therapy for locally advanced rectal cancer, potentially reducing side effects and improving long-term outcomes.
What could go wrong
This is a small, early-phase (phase 2) trial with only 60 participants, so results may not apply to all patients. The combination of treatments may still cause significant side effects, and the reduced radiation field might not control the tumor as well as standard therapy.

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 60 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Aug 2030

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: * Voluntarily agrees to participate and provides written informed consent * Age 18 to 75 years, male or female * Histologically confirmed rectal adenocarcinoma * MRI confirms that the upper margin of the tumor is ≤12 cm from the anal verge * ECOG performance status of 0-1 * Clinical stage T3-T4 or N+ and circumferential resection margin (CRM) positive by imaging evaluation; lateral lymph nodes negative * Immunohistochemistry or genetic testing indicates pMMR or MSS status * Adequate organ function and bone marrow reserve Exclusion Criteria: * Presence of distant metastasis * Prior pelvic radiotherapy * Chemotherapy or immunotherapy within the past 3 months * Refusal to undergo radical surgery for rectal cancer * Concurrent active malignancy other than rectal cancer * Positive antinuclear antibody (ANA) * History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis) * Elevated troponin above the normal range * Active tuberculosis * Positive hepatitis B surface antigen (HBsAg) or detectable HBV DNA * Positive for hepatitis C virus (HCV), syphilis, or HIV * Severe comorbid conditions (e.g., serious infection, severe bone marrow suppression, psychiatric disorder) deemed unsuitable for participation by the investigator * Pregnant or breastfeeding women * Any other contraindications to radiotherapy, chemotherapy, or immunotherapy

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Conditions

The condition(s) this trial relates to.

rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal adenocarcinoma

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

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016, China

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