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NCT06939439

Using ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer

Active, enrolled Phase 3 Last updated 1 July 2025
What this trial tests

Phase 3 trial testing Tislelizumab + SOX Chemotherapy in Gastric Cancer Stage III in 416 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 December 2024
Primary endpoint
31 December 2026
31 December 2029

Quick facts

Lead sponsorThe First Affiliated Hospital with Nanjing Medical University
PhasePhase 3
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment416
Start date1 December 2024
Primary completion31 December 2026
Estimated completion31 December 2029
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 80, any sex, with Gastric Cancer Stage III. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this randomized, controlled phase III clinical trial is to evaluate whether combining Tislelizumab with standard SOX chemotherapy improves disease-free survival (DFS) compared to chemotherapy alone in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive after surgery. The study will enroll 416 patients across multiple centers and will compare outcomes between two groups: patients receiving tislelizumab plus SOX chemotherapy and those receiving standard SOX chemotherapy alone. The primary questions to be addressed are whether the combination therapy improves 1-year DFS rates and whether it demonstrates an acceptable safety profile. Participants will provide tissue and blood samples for ctDNA-MRD testing, undergo postoperative adjuvant therapy (chemotherapy ± immunotherapy), and complete regular follow-up visits to monitor treatment response and safety. The trial will assess key outcomes, including DFS, overall survival (OS), and ctDNA clearance rates, to determine the clinical benefit and safety of tislelizumab in this population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Gastric Cancer Stage III

Currently open trials in the same condition.

Other The First Affiliated Hospital with Nanjing Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06939439.

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