Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With LA GC/GEJC
NCT06238167 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-02-02
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.
Conditions
Interventions
- 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).
Sponsors & Collaborators
-
First Affiliated Hospital of Wenzhou Medical University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2026-12-31
- Completion
- 2028-12-31
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