Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?

NCT ID NCT07810114

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This trial is taking on new participants right now.
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Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Stopped early, before it reached the end. That can be for many reasons, including safety.
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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.
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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

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First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether a combination of chemotherapy (mFOLFOX6) plus two immunotherapy drugs, suvemcitug and enlonstobart, can shrink high-risk mid-rectal cancer enough to safely skip pelvic radiation before surgery. The trial enrolls 52 adults with locally advanced rectal cancer that is pMMR/MSS, a type that often responds less well to immunotherapy alone. Everyone receives six cycles of the drug combination, then an MRI checks tumor regression. Those whose tumors shrink by at least 20% get two more chemotherapy cycles and surgery without radiation; those who do not respond get standard chemoradiation followed by more chemotherapy and surgery. The main goal is to see how many participants have no cancer cells left in the removed tissue.

What this could mean

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

Active substance
mFOLFOX6 chemotherapy combined with the immunotherapy drugs suvemcitug and enlonstobart
What this could lead to
If it works, some people with high-risk rectal cancer could avoid pelvic radiation and its long-term side effects while still getting their tumor removed.
What could go wrong
This is a small, single-arm Phase II study, so it cannot prove the approach is better than standard care. Some tumors may not shrink enough, and the immunotherapy drugs can cause immune-related 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 52 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 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: 1. Age 18 to 75 years, male or female. 2. Histologically confirmed rectal adenocarcinoma. 3. pMMR or MSS status confirmed by genetic testing or immunohistochemistry. 4. Tumor lower margin located 5-12 cm from the anal verge, based on colonoscopy or MRI, consistent with mid-rectal cancer. 5. Pelvic MRI showing high-risk locally advanced rectal cancer, meeting at least one of the following criteria: cT3c/d, defined as tumor extension \>5 mm beyond the muscularis propria; cN2 disease, defined as \>=4 regional metastatic lymph nodes; definite extramural venous invasion positivity. 6. No distant metastasis confirmed by chest and abdominal imaging, including contrast-enhanced CT or MRI. 7. ECOG performance status of 0 or 1. 8. Adequate organ function, including absolute neutrophil count \>=1.5 x 10\^9/L; platelet count \>=100 x 10\^9/L; hemoglobin \>=9 g/dL; ALT and AST \<=2.5 x upper limit of normal; total bilirubin \<=1.5 x upper limit of normal; serum creatinine \<=1.5 x upper limit of normal or creatinine clearance \>=50 mL/min. 9. Not pregnant or breastfeeding. Participants of reproductive potential must agree to use effective contraception during study treatment and for the protocol-specified period after the last dose. 10. Voluntary participation with signed written informed consent. Exclusion Criteria: 1. Imaging evidence of cT4 disease, mesorectal fascia positivity, or lateral lymph node metastasis. 2. Prior pelvic radiotherapy or prior systemic antitumor treatment for the current disease, including chemotherapy, targeted therapy, or immunotherapy. 3. Special histologic subtypes, including mucinous adenocarcinoma, signet-ring cell carcinoma, undifferentiated carcinoma, or other special histologic types. 4. Known allergy or contraindication to any component of the study drugs, including oxaliplatin, 5-fluorouracil, suvemcitug, or enlonstobart. 5. Active or previous severe autoimmune disease, including systemic lupus erythematosus or inflammatory bowel disease, or long-term use of systemic immunosuppressive agents. 6. Serious cardiovascular events within 6 months, including acute myocardial infarction or stroke, refractory hypertension, or NYHA class III-IV heart failure. 7. Active infection, including active tuberculosis, uncontrolled hepatitis B or C, or HIV infection with high viral load. 8. Other malignancy within 5 years, except cured localized skin cancer or carcinoma in situ. 9. Pregnancy or breastfeeding. 10. Inability to undergo MRI examination. 11. Multiple primary colorectal cancers. 12. Intestinal obstruction, intestinal perforation, or high risk of obstruction or perforation. 13. Hypertension that cannot be controlled to the normal range with antihypertensive therapy, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg. 14. NYHA class III-IV cardiac insufficiency or left ventricular ejection fraction \<50% on echocardiography. 15. Proteinuria, defined as urine protein \>1+ at screening, or urine protein 1+ that does not return to normal on repeat testing within 24 hours. 16. Definite tendency for gastrointestinal bleeding, including active local ulcerative lesions with fecal occult blood positivity of ++; history of melena or hematemesis within 2 months; high risk of bleeding such as grade \>=3 bleeding within 6 months, hemoptysis \>=2.5 mL per episode, imaging evidence of tumor invasion into major blood vessels, or bleeding risk deemed unacceptable by the investigator. 17. High risk of gastrointestinal perforation or fistula, including gastrointestinal perforation or active peptic ulcer within 6 months, or pelvic tumor invasion of the bladder or rectum with potential fistula risk as judged by the investigator. 18. Coagulation abnormality, including INR \>1.5 or APTT \>1.5 x upper limit of normal, with bleeding tendency. 19. Chronic unhealed wound or fracture; major surgery within 4 weeks; or severe traumatic injury, fracture, or ulcer within 4 weeks. 20. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment or unlikely to comply with follow-up.

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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

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Contacts and locations

Locations

  • Department of General Surgery, Zhongshan Hospital, Fudan University

    Shanghai, 200032, China

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