drugset / Trial / NCT05687357
Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma
Phase 2
Recruiting
140 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-03-15
- Primary completion
- 2027-02-28
- Completion
- 2027-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 120 mg/m2 | Intravenous |
| Background | S-1 | Small molecule | — | Oral |