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ACTIVE NOT RECRUITING
NCT03691454
PHASE2/PHASE3

Compare Neoadjuvant DOS Combined With Toripalimab Versus SOX Combined With Toripalimab in Locally Advanced Gastric Adenocarcinoma

Sponsor: Peking University

View on ClinicalTrials.gov

Summary

This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab versus oxaliplatin and S-1 (SOX) plus toripalimab in patients with locally advanced gastric adenocarcinoma.

Official title: A Randomized, Multicenter, Controlled, Adaptive II/III Study to Compare Neoadjuvant Chemotherapy of Docetaxel, Oxaliplatin, S-1(DOS) Combined With Toripalimab Versus Oxaliplatin, S-1(SOX) Combined With Toripalimab in Locally Advanced Gastric Adenocarcinoma (RESOLVE-2 Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2018-06-28

Completion Date

2027-06-30

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

DRUG

Docetaxel+Oxaliplatin+S-1+Toripalimab

Docetaxel 50mg/m2, intravenous drip, D1, combined with Oxaliplatin 85mg/m2, intravenous drip 2h, D1 and S-1 40-60mg bid, orally, D1-7 (BSA\<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid); Toripalimab, intravenous drip, 3mg/kg, D1 when combined with chemotherapy, or 240mg, D1 as monotherapy; every 14 days for a cycle during combination therapy and every 21 days for a cycle during Toripalimab monotherapy.

DRUG

Oxaliplatin+S-1+Toripalimab

Oxaliplatin 130mg/m2, intravenous drip 2h, D1, combined with S-1 40-60mg bid, orally, D1-14 (BSA\<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid) and Toripalimab 240mg, intravenous drip, D1; every 21 days for a cycle.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China