NCT05687357

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer
• Gastroesophageal-junction Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	IV infusion
DRUG	S-1	Oral tablets
DRUG	Oxaliplatin	IV infusion
DRUG	Nab paclitaxel	IV infusion
RADIATION	Radiation	TOMO/VMAT

Timeline

• Start date: 2023-03-15
• Primary completion: 2027-02-28
• Completion: 2027-08-31
• First posted: 2023-01-18
• Last updated: 2023-04-19

Locations

3 sites across 1 country: China