Using ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2029

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.

Trial Locations (1)

210029

First Affiliated Hospital with Nanjing Medical Unviersity, Nanjing

All Listed Sponsors
collaborator

First Affiliated Hospital of Suzhou Medical College

OTHER

collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

collaborator

Nanjing Gaochun People's Hospital

OTHER

collaborator

The Affiliated Jiangning Hospital of Nanjing Medical University

OTHER

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER

NCT06939439 - Using ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer | Biotech Hunter | Biotech Hunter