Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma
Trial Parameters
Brief Summary
This study is a prospective, multi-center, randomized controlled phase II trial to compare the efficacy of perioperative SOX plus toripalimab, toripalimab monotherapy with SOX regimen in participants with dMMR locally advanced gastric or esophagogastric junction adenocarcinoma
Eligibility Criteria
Inclusion Criteria: 1. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF). 2. Participants were ambulatory male or female. Age: ≥ 18 years and ≤ 80 years old. 3. Histopathologically confirmed gastric or esophagogastric junction adenocarcinoma. 4. Mismatch repair deficient (dMMR) adenocarcinoma, which was determined by immunohistochemistry (ICH) test of endoscopic biopsy specimen. dMMR was defined as loss of nuclear expression of one or more MMR proteins. 5. cT2-4bN+/-, M0 according to the American Joint Committee on Cancer and Union for International Cancer Control (AJCC-UICC) TNM classification for carcinoma of the stomach (8th edition). 6. Participants had Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1 within 7 days before the first dose of study treatment. 7. Life expectancy ≥ 6 months. 8. Agreement of providing baseline and surgical specimens for biomarker analysis.