New cocktail of drugs and viruses aims to shrink rectal tumors without surgery
NCT ID NCT07543848
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
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- 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 80 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: \- 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.
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The places running it
1 site. 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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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
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Other studies related to the condition(s) this trial covers.
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- Can Pre-Surgery radiation stop rectal cancer from returning?