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RECRUITING
NCT05687357
PHASE2

Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.

Official title: Tislelizumab in Combination With Pre-operative Chemoradiotherapy Versus SOC for Patients With Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Multicenter, Randomized, Open-label, Phase IIB Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2023-03-15

Completion Date

2027-08-31

Last Updated

2023-04-19

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

IV infusion

DRUG

S-1

Oral tablets

DRUG

Oxaliplatin

IV infusion

DRUG

Nab paclitaxel

IV infusion

RADIATION

Radiation

TOMO/VMAT

Locations (3)

Wuhan Tongji Hospital

Wuhan, Hubei, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China