NCT06238167

Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With LA GC/GEJC

A Single Arm, Phase 2 Clinical Study Evaluating the Efficacy and Safety of Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with tislelizumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or tegafur-gimeracil-oteracil potassium + oxaliplatin (SOX therapy) in PD-L1 CPS positive, elderly (≥70years old), pStage III gastric cancer (including esophagogastric junction cancer) after D2 dissection.

Detailed description

This is a prospective single-arm study to explore the safety and tolerability of chemotherapy combined with tislelizumab as postoperative adjuvant therapy in PD-L1 CPS positive, elderly, stage III gastric cancer/gastroesophageal junction adenocarcinoma. Enrolled patients will receive chemotherapy combined with tislelizumab postoperative adjuvant therapy. Chemotherapy regimens were determined by the investigator as S-1 therapy or low dose SOX therapy: S-1 therapy: S1 d1-14 bid (\< 1.25m\^ 40mg, 1.25m\^2-1.5m2 50mg, ≥ 1.5m\^2 60mg), followed by 7 days off (Q3W, max 16 cycles). SOX treatment: oxaliplatin: 78mg/m2, d1, S-1: 50mg d1-14 bid, followed by 7 days off (Q3W, max 8 cycles). Immunotherapy: Tislelizumab, 200mg Q3W, max 16 cycles. The Primary endpoint is 1-year disease-free survival rate. The secondary endpoints included: 1. 2-year disease-free survival rate, 3-year disease-free survival rate. 2. 2-year overall survival rate, 3-year overall survival rate. 3. Median disease-free survival 4. Median overall survival 5. Safety

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab, 200mg Q3W, max 16 cycles.
DRUG	S-1 therapy	S1 d1-14 bid (\< 1.25m\^2 40mg, 1.25m\^2-1.5m\^2 50mg, ≥ 1.5m\^2 60mg), followed by 7 days off (Q3W, max 16 cycles).
DRUG	low dose SOX therapy	Oxaliplatin: 78mg/m\^2, d1, S-1: 50mg d1-14 bid, followed by 7 days off (Q3W, max 8 cycles).

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-02-02
• Last updated: 2024-02-02