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Could some GI cancer patients avoid major surgery? new study explores organ preservation

NCT ID NCT07642323

Disease control Sponsor: Peking University Cancer Hospital & Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at whether people with certain genetic types of gastrointestinal cancers (stomach, colorectal, or anal) can safely avoid major surgery after immunotherapy. Instead of removing the organ, doctors will monitor closely or do smaller procedures to remove any remaining cancer. The goal is to see if this gentler approach works as well as surgery and helps patients have a better quality of life. About 22 participants will be enrolled.

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

About 22 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 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.

Who is studied

The target population consists of adult patients diagnosed with primary gastrointestinal cancers (including but not limited to colorectal cancer, gastric cancer, and gastroesophageal junction cancer) that are histologically confirmed as deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or harboring polymerase epsilon (POLE) exonuclease domain mutations. All enrolled patients must have received or are scheduled to receive neoadjuvant or conversion immunotherapy prior to definitive local tumor management strategy determination.

Ages

18 years and older

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: * Histologically confirmed primary gastrointestinal adenocarcinoma or squamous cell carcinoma (e.g., colorectal cancer, gastric cancer, gastroesophageal junction cancer). * Confirmed as deficient mismatch repair (dMMR) by immunohistochemistry (IHC), high microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next-generation sequencing (NGS), or harboring POLE exonuclease domain mutations. * Received neoadjuvant/conversion immunotherapy (immune checkpoint inhibitors, either monotherapy or combination therapy) prior to treatment response evaluation. * For the Retrospective Cohort (Part 1): Patients treated between \[Start Month/Year\] and \[End Month/Year\] who completed evaluation and subsequent strategy (NOM/OPFS or RO). * For the Prospective Cohort (Part 2): Newly diagnosed patients who consent to long-term follow-up and multi-disciplinary team (MDT) assessment for organ preservation or radical surgery. * Age ≥ 18 years at the time of diagnosis. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Concurrently diagnosed with other active malignant tumors within the past 5 years. * Patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) tumors, or wild-type POLE status. * Evidence of untreatable distant metastasis or systemic disease that precludes local tumor management (NOM/OPFS or radical operation). * Inability to undergo regular endoscopic, radiological (MRI/CT), or clinical follow-up due to compliance or geographic reasons. * Refusal to sign the informed consent form (applicable to the prospective cohort).

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Conditions

The condition(s) this trial relates to.

anus cancer colorectal cancer colorectal neoplasm digestive system cancer digestive system neoplasm gastric cancer gastric neoplasm

As listed by the trial registrant

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

Gastrointestinal cancers Gastrointestinal cancers - anus Gastrointestinal cancers - colorectal Gastrointestinal cancers - stomach

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.