Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT06238167
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
Study:
NCT06238167
Study Brief:
Protocol Section:
NCT06238167