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

Gastric Cancer Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT06238167
• Study type: Interventional
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Jun Cheng
• Phone: 86-13600668439
• Email: 1043475708@qq.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2024
• Completion date: December 31, 2028