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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
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
Tislelizumab
IV infusion
S-1
Oral tablets
Oxaliplatin
IV infusion
Nab paclitaxel
IV infusion
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