Neoplasms

Digestive System Diseases

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Rare Diseases

Stomach Neoplasms

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Tislelizumab

Oxaliplatin

Antineoplastic Agents, Immunological

Treatment arm(Tislelizumab+S-1/SOX)

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

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).

S-1 therapy

Oxaliplatin: 78mg/m\^2, d1, S-1: 50mg d1-14 bid, followed by 7 days off (Q3W, max 8 cycles).

low dose SOX therapy

Jun Cheng

Shuqing Jin

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.

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

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

First Affiliated Hospital of Wenzhou Medical University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With LA GC/GEJC	NCT06238167	Gastric Cancer	Tislelizumab S-1 therapy low dose SOX th...	70 Years -	First Affiliated Hospital of Wenzhou Medical University
Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With LA GC/GEJC	NCT06238167	Gastric Cancer	Tislelizumab S-1 therapy low dose SOX th...	70 Years -	First Affiliated Hospital of Wenzhou Medical University

Spots Global Cancer Trial Database for low dose sox therapy