MSI/dMMR tumors or EBV+ gastric cancer
Conditions
Brief summary
The primary endpoint will be the rate of complete pathological response (pCR) after surgery according to local pathological evaluation. A complete pathological response will be defined as 0% viable tumor cells in tumor or nodal site (ypT0N0).
Detailed description
Safety profile, Rate of surgical complications, Percentage of patients with R0 resection, Percentage of patients with major pathological response, RFS, Percentage of patients with objective response 4, 10, 16 and 21 weeks, Percentage of patients with second cancer in the Lynch syndrome spectrum, OS, PFS, QoL, Association between LIPI score and the response to treatment, In the subgroup of patients without surgery: Progression free survival (PFS),
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Centre Leon Berard
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the rate of complete pathological response (pCR) after surgery according to local pathological evaluation. A complete pathological response will be defined as 0% viable tumor cells in tumor or nodal site (ypT0N0). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile, Rate of surgical complications, Percentage of patients with R0 resection, Percentage of patients with major pathological response, RFS, Percentage of patients with objective response 4, 10, 16 and 21 weeks, Percentage of patients with second cancer in the Lynch syndrome spectrum, OS, PFS, QoL, Association between LIPI score and the response to treatment, In the subgroup of patients without surgery: Progression free survival (PFS), | — |
Countries
France
Outcome results
None listed