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RECRUITING
NCT04989985
PHASE2

S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

For locally advanced adenocarcinoma of esophagogastric junction(AEG) (cT3-4aN+M0), neoadjuvant chemotherapy was improved to downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced AEG could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Sintilimab in this study is an anti-PD-1 monoclonal antibody for injection which has been approved for several malignant tumors. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of sintilimab in combination with perioperative chemotherapy in locally advanced AEG.

Official title: Perioperative SOX Plus Sintilimab Compared With Perioperative SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: an Open-label, Phase 2 Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

302

Start Date

2021-09-01

Completion Date

2027-08-01

Last Updated

2021-08-04

Healthy Volunteers

No

Interventions

DRUG

Oxaliplatin+S-1

Drug: Oxaliplatin Oxaliplatin: 130mg/m2,iv drip for 2h,d1, q3w Drug: S-1 S-1: 40\~60mg Bid,d1\~14, q3w

DRUG

Sinitilimab+oxaliplatin+S-1

Drug: Sintilimab Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg ivdrip, d1, q3w. Other Name: PD-1 antibody Drug: Oxaliplatin Oxaliplatin: 130mg/m2,iv drip for 2h,d1, q3w Drug: S-1 S-1: 40\~60mg Bid,d1\~14, q3w

Locations (1)

The sixth affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China