Spots Global Cancer Trial Database for Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With LA GC/GEJC

Study Description

Brief 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

Keywords

Eligibility

Minimum Age: 70 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial