A Prospective, Open-label, Single-Arm, Phase II Study on Biomarkers for Predicting the Efficacy of Neoadjuvant Sintilimab in Combination With Tegafur and Oxaliplatin (SOX) for cStage III Gastric or Gastroesophageal Junction Adenocarcinoma.

NCT05594381 Phase 2 UNKNOWN

Recently, a number of clinical studies were carried out to evaluate the therapeutic effects of PD-1 antibodies combined with chemotherapy as preoperative neoadjuvant therapy of gastric cancer (GC) worldwide. Indicators such as PD-L1 expression, TMB and MSI are currently used to evaluate the efficacy of PD-1/PD-L1 monoclonal antibody therapy. However, these biomarkers are mainly used in patients with metastatic and unresectable tumors, and the conclusions obtained in different studies are still partially contradictory, failing to accurately guide the treatment. Therefore, it is urgent to explore highly sensitive and specific biomarkers that can be used to monitor the efficacy of neoadjuvant immunotherapy for GC.The present clinical trial aims to use ctDNA dynamic monitoring combined with multi-omics methods to evaluate PD-1 monoclonal antibody (sintilimab) combined with SOX neoadjuvant therapy for clinical stage III gastric/gastroesophageal junction adenocarcinoma. In order to identify the suitable population for neoadjuvant immunotherapy for locally advanced and resectable G/GEJ adenocarcinoma.

Details

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	Phase 2
Status	UNKNOWN
Enrolment	90
Start date	2022-10
Completion	2025-10

Conditions

• Gastric Cancer

Interventions

• Sintilimab

Primary outcomes

• Pathological complete response rate (pCR) — an average of 6 months.
  pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens. The primary aim of the study is to test the hypothesis that after neoadjuvant therapy，patients with ctDNA clearance result in a higher rate of pCR.