A future without surgery for stomach and colon cancers?
NCT ID NCT07775859
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study tests whether people with certain gastrointestinal cancers—like stomach, esophageal, or colorectal—can safely skip radical surgery after responding well to precision therapies such as immunotherapy or targeted drugs. Participants with specific molecular markers will be evaluated by a team of experts and may receive non-operative management, local treatment, or surgery. The goal is to see if organ preservation can offer similar cancer control while improving function and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Molecular biomarker-guided non-operative management and organ preservation strategy after precision therapy (immune checkpoint inhibitors or targeted therapy)
- What this could lead to
- If successful, this could establish a new paradigm where some gastrointestinal cancers are managed without radical surgery, preserving organs and improving quality of life while maintaining cancer control.
- What could go wrong
- This is an early-stage, single-center study, and organ preservation may not provide the same long-term cancer control as surgery. There is also a risk of disease recurrence without radical resection.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
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
The study population will consist of adult patients with histologically confirmed gastrointestinal cancers who are treated at Peking University Cancer Hospital and who have at least one actionable molecular biomarker relevant to immune checkpoint inhibitor therapy, targeted therapy, or other precision treatment strategies. Eligible participants will be identified from the institutional gastrointestinal oncology clinical practice and research database and enrolled into retrospective or prospective cohorts according to the availability of eligible clinical data and the timing of study enrollment.
- Ages
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18 years and older
- 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. Adults aged 18 years or older at the time of study enrollment. 2. Histologically confirmed gastrointestinal malignancy, including gastric cancer, gastroesophageal junction cancer, esophageal cancer, or colorectal cancer. 3. Presence of at least one molecular biomarker that may support selection of precision therapy, including but not limited to: * Mismatch repair deficiency or microsatellite instability-high (dMMR/MSI-H); * Pathogenic or likely pathogenic POLE or POLD1 mutation; * High programmed death ligand 1 combined positive score (PD-L1 CPS), when applicable to the tumor type and treatment strategy; * Tumor mutational burden-high (TMB-H); * Epstein-Barr virus-positive status (EBV-positive), when applicable; * Human epidermal growth factor receptor 2 (HER2) positivity; * Claudin 18.2 (CLDN18.2) positivity; * Fibroblast growth factor receptor 2 (FGFR2) alteration; * Mesenchymal-epithelial transition factor (MET) amplification or other actionable MET alteration; * Neurotrophic tyrosine receptor kinase (NTRK) gene fusion; * Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation; * Other clinically actionable molecular alterations recognized according to contemporary clinical practice. 4. Receipt of molecular biomarker-guided precision therapy before assessment for non-operative management or organ-preservation strategy. Precision therapy may include immune checkpoint inhibitor therapy, targeted therapy, or a combination of systemic therapies according to the participant's tumor type, molecular profile, clinical stage, and standard clinical practice. 5. After completion or adequate exposure to precision therapy, achievement of a favorable clinical response that may support consideration of non-operative management or organ-preservation strategy, including clinical complete response (cCR), near-complete response (near-cCR), major tumor regression, or other predefined favorable response categories. 6. Multidisciplinary team (MDT) evaluation has been performed to determine whether non-operative management, local treatment, organ-preservation strategy, or radical surgery is appropriate. 7. Adequate clinical information is available for assessment of treatment response, including appropriate imaging, endoscopic evaluation, pathological evaluation, or other clinically indicated examinations. 8. Ability and willingness to comply with the predefined surveillance and follow-up schedule. 9. For the prospective cohort, written informed consent is obtained before enrollment and study-specific data collection. 10. For the retrospective cohort, eligible clinical data are available in the institutional medical records and may be used according to institutional ethics approval and applicable regulations. Exclusion Criteria: 1. Uncontrolled progressive metastatic disease or clinical deterioration that precludes evaluation for the study treatment strategy. 2. Patients who are unable to undergo appropriate clinical, radiological, endoscopic, or pathological assessment required for response evaluation or follow-up. 3. Previous treatment history or concurrent medical conditions that, in the judgment of the multidisciplinary team, preclude reliable assessment of tumor response or implementation of the predefined surveillance strategy. 4. Severe comorbidities or medical conditions that make continued follow-up or additional treatment evaluation clinically inappropriate. 5. Inability or unwillingness to comply with the predefined follow-up schedule. 6. Withdrawal of informed consent for prospective participants. 7. Insufficient clinical information to determine eligibility, treatment response, treatment strategy, or follow-up outcomes. 8. Patients with conditions that require immediate radical surgery or other urgent treatment according to multidisciplinary clinical assessment and who cannot safely undergo the predefined study evaluation.
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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 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.
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