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Using ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer

NCT06939439 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2025-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Gastric Cancer Stage III

Interventions

DRUG

Tislelizumab + SOX Chemotherapy

The intervention in this study involves the use of tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody, in combination with the standard SOX chemotherapy regimen for postoperative adjuvant therapy in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive. Tislelizumab is administered at a dose of 200 mg intravenously every 3 weeks for a total duration of 1 year, alongside 6-8 cycles of SOX chemotherapy. The SOX regimen includes oxaliplatin (130 mg/m² intravenously every 3 weeks) and tegafur, with the dose of tegafur determined based on body surface area and administered orally twice daily for 14 days every 3 weeks.

DRUG

SOX Chemotherapy

The control group will receive standard SOX chemotherapy alone, serving as an active comparator to evaluate the incremental benefit of adding tislelizumab. This design ensures a rigorous comparison while maintaining alignment with current standard-of-care practices.

Sponsors & Collaborators

  • First Affiliated Hospital of Suzhou Medical College

    collaborator OTHER

  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER

  • Nanjing Gaochun People's Hospital

    collaborator OTHER

  • The Affiliated Jiangning Hospital of Nanjing Medical University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939439 on ClinicalTrials.gov