- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646574
Non-surgical Management After NIT for dMMR/MSI-H GC
Non-surgical Management After Neoadjuvant Immunotherapy for Locally Advanced dMMR/MSI-H Gastric Cancer: WWWGC Phase II Study
Study Overview
Status
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients over 18 years old with advanced dMMR/MSI-H gastric cancer; Neoadjuvant therapy is needed (immunotherapy, chemotherapy + immunotherapy); The patient voluntarily and agreed to join the clinical research.
Exclusion Criteria:
Gastric cancer combined with invasion and metastasis; Gastric cancer combined with other malignant tumors; Gastric cancer combined with dysfunction of other organs; Unwilling to participate in clinical research.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence-free survival (RFS)
Time Frame: One year, three years, or five years after the end of immunotherapy
|
The recurrence-free survival time of gastric cancer patients
|
One year, three years, or five years after the end of immunotherapy
|
|
Overall survival (OS)
Time Frame: One year, three years, or five years after the end of immunotherapy
|
The period from the start of randomization grouping in a clinical trial to the death of a patient for any cause
|
One year, three years, or five years after the end of immunotherapy
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ChiCTR2600120174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-surgical Management;dMMR/MSI-H Gastric Cancer;Neoadjuvant Immunotherapy
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Servier Bio-Innovation LLCMerck Sharp & Dohme LLC; Institut de Recherches Internationales ServierActive, not recruitingMSI-H/dMMR Gastroesophageal-junction Cancer | MSI-H/dMMR Gastric CancerFrance, United States, China, Belgium, Denmark, Spain, Australia, Italy, Canada, Brazil, Japan, Puerto Rico, Hungary, Austria, United Kingdom
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Eikon TherapeuticsMerck Sharp & Dohme LLCRecruitingAdvanced Solid Tumors | Endometrial Cancer | Mismatch Repair Deficient or MSI-High Solid Tumors | MSI-H or dMMR Advanced Solid Tumors | MSI-H/dMMR Gastroesophageal-junction Cancer | MSI-H/dMMR Gastric Cancer | MSI-H/dMMR Colorectal CancerUnited States, Australia, New Zealand
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Royal Marsden NHS Foundation TrustGilead SciencesRecruitingLocally Advanced Gastric Adenocarcinoma | MSI-H/dMMR Gastroesophageal-junction Cancer | MSI-H/dMMR Gastric CancerUnited Kingdom
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Peking UniversityActive, not recruitingMSI-H/dMMR Gastric Carcinoma and Colorectal CancerChina
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Fudan UniversityNot yet recruitingGastric Cancer | MSI-H | Adjuvant Therapy | PD-1 ImmunotherapyChina
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Sun Yat-sen UniversityRecruitingColorectal Cancer | Neoadjuvant Therapy | Mismatch Repair-deficient (dMMR) | Microsatellite Instability-high (MSI-H)China
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Peking UniversityRecruitingGastric Cancer | Colon Cancer | MSI-H | DMMR CancerChina
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Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingColorectal Cancer | Neoadjuvant Therapy | Mismatch Repair-deficient (dMMR) | Microsatellite Instability-high (MSI-H)China
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LiuYingNot yet recruitingColorectal Cancer | Neoadjuvant Therapy | Mismatch Repair-deficient (dMMR) | Microsatellite Instability-high (MSI-H)China
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Medicenna Therapeutics, Inc.Merck Sharp & Dohme LLCRecruitingClear Cell Renal Cell Carcinoma | Cervical Cancer | Gastric Cancer | Esophageal Cancer | Ovarian Cancer | Fallopian Tube Cancer | Solid Tumor | Squamous Cell Carcinoma of Head and Neck | Bladder Cancer | Skin Cancer | Triple Negative Breast Cancer | Advanced Solid Tumor | Endometrial Cancer | Primary Peritoneal Cancer and other conditionsUnited States, Australia, Spain, Portugal, Ireland, Canada, Korea, Republic of