Gastroesophageal/Gastric adenocarcinoma
Conditions
Interventions
Observation group of surgically resectable locally advanced tumors (Cohort 1):None
Unresectable/metastatic/recurrent diseases (Cohort 2):None
Sponsors
Zhongshan Hospital, Fudan Univeristy
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–85 years, either sex. 2.Histologically documented gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (Siewert types II or III only). 3.dMMR status confirmed by immunohistochemistry OR MSI-H status confirmed by PCR or next-generation sequencing. 4.Clinical tumor stage: • cT = 2, any N, M0, deemed resectable by the investigator, and scheduled to receive neoadjuvant therapy followed by surgery (Cohort 1); • judged unresectable, or presence of distant metastases, or recurrent disease, or deemed medically unfit for surgery by the investigator, and scheduled for systemic therapy (Cohort 2). 5.Treatment with immune-checkpoint inhibitors (e.g., anti–PD-1, anti–PD-L1, anti–CTLA-4, bispecific PD-1/CTLA-4 antibodies), administered as monotherapy or in combination with standard gastric cancer chemotherapy regimens.
Exclusion criteria
Exclusion criteria: 1.Tumor histology other than adenocarcinoma (e.g., squamous-cell carcinoma, neuroendocrine carcinoma). 2.Central nervous system metastases and/or leptomeningeal carcinomatosis. 3.Prior anti-tumor therapy for the current gastric cancer, except for bypass surgery performed solely for symptomatic relief of obstruction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival;Event-free survival;Major pathological response rate; | — |
Countries
China
Contacts
Public ContactZhaoqing Tang
Zhongshan Hospital, Fudan University
Outcome results
None listed