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New cocktail of drugs and viruses aims to shrink rectal tumors without surgery

NCT ID NCT07543848

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 mix of immunotherapy, a cancer-killing virus, short-course radiation, and chemotherapy in 20 people with locally advanced low rectal cancer. The goal is to see if this combination can make the tumor disappear completely for at least a year, potentially allowing patients to avoid major surgery. The study will closely monitor tumor response and side effects.

What this could mean

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

Active substance
serplulimab (PD-1 inhibitor), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy
What this could lead to
If successful, this combination could increase the chance of a complete response and allow more patients to avoid surgery, preserving the rectum.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply widely. The combination of multiple treatments 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 20 people

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

Expected to start

May 2026

An estimate. Start dates often move.

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 80 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 meet all of the following criteria: 1. Age 18 to 80 years, male or female. 2. Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge. 3. Clinical stage T1-3N0M0 according to AJCC staging criteria. 4. Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing. 5. No prior anti-tumor treatment. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of at least 3 months. 7. Adequate organ function, including: * Absolute neutrophil count ≥1.5 × 10\^9/L * Platelet count ≥100 × 10\^9/L * Hemoglobin ≥9 g/dL * Serum albumin ≥3 g/dL * Total bilirubin ≤1.5 × upper limit of normal (ULN) * ALT and AST ≤2 × ULN * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min * INR or PT ≤1.5 × ULN, and aPTT ≤1.5 × ULN 8. Thyroid function within normal range or adequately controlled. 9. Negative pregnancy test for women of childbearing potential. 10. Willingness to use effective contraception during the study and for 12 months after treatment. 11. Ability to understand and willingness to sign a written informed consent form. 12. Willingness and ability to comply with study procedures and follow-up. Exclusion Criteria: * Participants will be excluded if they meet any of the following criteria: 1. Histology other than rectal adenocarcinoma (e.g., gastrointestinal stromal tumor, lymphoma). 2. Prior pelvic radiotherapy. 3. Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors. 4. Known allergy to study drugs or their components. 5. History of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma. 6. Active autoimmune disease or history of autoimmune disease requiring systemic treatment. 7. Immunodeficiency, including HIV infection, or history of organ transplantation. 8. History of interstitial lung disease or non-infectious pneumonitis. 9. Active tuberculosis infection or history of untreated tuberculosis. 10. Active hepatitis B or hepatitis C infection. 11. Severe cardiovascular, pulmonary, or renal disease. 12. Uncontrolled hypertension despite medication. 13. History of substance abuse (alcohol or drugs). 14. Active uncontrolled infection. 15. Use of systemic immunosuppressive therapy. 16. Pregnant or breastfeeding women. 17. Any condition that, in the investigator's opinion, may interfere with study participation or safety.

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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.

  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

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

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