Immunotherapy may let some GI cancer patients skip the knife
NCT ID NCT07656740
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether immunotherapy can shrink certain gastrointestinal cancers (like colorectal or stomach cancer) enough that some patients may not need major surgery. People whose tumors have specific genetic features (MSI-H/dMMR or POLE mutation) and who respond well to immunotherapy may be able to simply watch and wait or have a minor procedure instead of a radical operation. The goal is to see if this approach can preserve organ function and avoid permanent colostomy while keeping the cancer under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- immunotherapy (neoadjuvant)
- What this could lead to
- If successful, this could allow some patients with certain GI cancers to avoid major surgery and preserve organ function.
- What could go wrong
- This is an early-stage study with only 50 participants, so results may not apply broadly. There is a risk that the cancer may return without surgery.
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.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
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.
Who is studied
Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: 1. Retrospective Cohort Inclusion Criteria * Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable. * Completed prior immunotherapy. * No evidence of distant metastasis. * Managed with W\&W, LE, endoscopic surgery, or radical operation after treatment. 2. Prospective Cohort Inclusion Criteria * Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Immunotherapy status: naive, currently receiving, or completed treatment, and evaluated by the PKUCH-NOMIC research group as cCR/near-cCR or Non-cCR (≤ ymrT2N0). * No evidence of distant metastasis. * Absence of emergencies requiring immediate surgery (e.g., hemorrhage, perforation, obstruction). Exclusion Criteria: * Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases. * Serum creatinine \> 1.5 times upper limit of normal (ULN). * History of pelvic radiation therapy.Inability to tolerate MRI examinations. * History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma). * Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack \[TIA\], cerebral vascular accident \[CVA\]). * Prior receipt of other types of investigational anti-tumor therapies. * Pregnant or lactating women. * Concomitant diseases or mental health conditions that may interfere with study participation.
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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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Peking University Cancer Hospital
Beijing, Haidian District, 100142, China
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