drugset
drugset / Trial / NCT05918094

Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma

NCT05918094 ↗

Phase 3 Recruiting 540 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.

Timeline

Start
2023-04-30
Primary completion
2026-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 600 mg/m2 Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Oxaliplatin Small molecule 78 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous

Indications

gastric cancer