Actively Recruiting
Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study
Led by GERCOR - Multidisciplinary Oncology Cooperative Group · Updated on 2024-02-05
59
Participants Needed
2
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II study will evaluate dostarlimab with a watch-and-wait approach for patients with localized mismatch repair deficiency (dMMR)/microsatellite instability (MSI) gastric or oeso-gastric junction adenocarcinoma. The goal of the study is to determine whether the surgery could be avoided in patients with localized dMMR/MSI-H gastric/OGJ adenocarcinoma with complete response at endoscopy and biopsies free of tumoral cells after treatment with dostarlimab, with a watch-and-wait approaches.
CONDITIONS
Official Title
Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed and dated informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Aged 18 to 75 years; patients over 75 eligible if G8 questionnaire score is above 14 and eligible for surgery without contraindications to repeated upper gastrointestinal endoscopy with biopsies
- Histologically confirmed non-metastatic gastric or oeso-gastric junction adenocarcinoma, clinical stage cT2 to T4, Nx, M0 by CT and echo-endoscopy
- No peritoneal carcinomatosis confirmed by imaging or optional coelioscopy
- No prior treatment with chemotherapy, radiotherapy, or immunotherapy for localized gastric or oeso-gastric junction adenocarcinoma
- Tumor confirmed to be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) by immunohistochemistry and PCR testing, with confirmation by sponsor
- Adequate blood counts: absolute neutrophil count ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL
- Adequate kidney function with serum creatinine ≤150 µM and clearance ≥50 ml/min
- Adequate liver function with bilirubin, alkaline phosphatase, ALT, and AST within specified limits
- Coagulation tests (INR, PT, aPTT) within 1.5 times upper limit of normal or appropriate therapeutic range if on anticoagulants
- Radiologic tumor assessment within 28 days before inclusion showing no metastasis
- Female participants not pregnant or breastfeeding, with negative pregnancy test if of childbearing potential, and willing to use effective contraception during and 4 months after treatment
- Male participants agreeing to use contraception and refrain from sperm donation during and 4 months after treatment
- Providing primary tumor tissue samples and images from endoscopy
- Willing and able to comply with study visits and requirements
- Registered in a National Health Care System (Protection Universelle Maladie included)
You will not qualify if you...
- Prior unplanned antitumor therapy such as chemotherapy, targeted therapy, or immunotherapy
- Use of investigational drugs within 28 days before study entry
- Anticoagulant treatment or bleeding disorders contraindicating biopsies
- Major surgery within 28 days before first dose
- Serious uncontrolled non-malignant diseases or active infections making participation unsafe
- Other malignancies except certain treated cancers in complete remission for 3 or more years
- Presence of metastatic disease
- Pregnancy or breastfeeding
- HIV infection
- Active hepatitis B or C infection; past resolved infections allowed with specific testing
- Legal incapacity or inability to consent
- Inability to comply with medical follow-up due to geographic, social, or psychiatric reasons
- Pyloric tumors due to risk of obstruction
- History of autoimmune diseases except stable hypothyroidism or controlled type 1 diabetes
- History or evidence of pneumonitis or pulmonary fibrosis
- Receipt of live vaccines within 14 days before treatment
- Prior treatment with immune checkpoint inhibitors
- Prior bone marrow or solid organ transplantation
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before treatment or expected need during study, with some exceptions for low-dose or topical steroids
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CHRU Lille
Lille, France
Actively Recruiting
2
Hôpital Saint Antoine
Paris, France
Actively Recruiting
Research Team
M
Marie-Line GARCIA LARNICOL, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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