NCT07068516

Perioperative Tislelizumab Plus Chemotherapy Versus Chemotherapy Alone in MHC-II-Positive Gastric/GEJ Cancer

A Multicenter, Randomized, Double-blind, Phase III Clinical Trial of Tislelizumab Combined With Chemotherapy Versus Placebo Plus Chemotherapy as Perioperative Treatment for MHC Class II-positive Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (estimated)
• Sponsor: Xiangdong Cheng · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Investigators has conducted a series of studies on patient selection for perioperative immunotherapy in locally advanced gastric cancer. Results from prospective single-arm trial (NCT05739045) demonstrated that 21.74% of patients achieved pathological complete response (pCR) after receiving neoadjuvant nivolumab combined with SOX regimen. Notably, investigators identified that the sensitive group exhibited upregulated MHC-II expression in malignant cells at baseline, with enriched pathways including interferon-gamma signaling and MHC class II antigen presentation. The pCR rate was significantly higher in MHC-II positive patients compared to MHC-II negative patients (36.84% vs 11.11%, P=0.038). Subsequent retrospective analyses and another prospective single-arm study focusing on MHC-II positive populations consistently showed superior short-term treatment outcomes with immunotherapy plus chemotherapy in this subgroup. Building upon these preliminary findings from small-scale studies and considering current developments in the field, we are now initiating this multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The study aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy versus placebo plus chemotherapy as perioperative treatment for MHC-II positive patients with locally advanced gastric or gastroesophageal junction adenocarcinoma.

Conditions

• Gastric Cancer Stage

Interventions

Type	Name	Description
DRUG	Tislelizumab	Received tislelizumab combined with investigator's choice of chemotherapy
DRUG	SOX or CAPOX regimen	chemotherapy (SOX or CAPOX regimen)

Timeline

• Start date: 2025-07-20
• Primary completion: 2027-06-30
• Completion: 2030-06-30
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: China