drugset / Trial / NCT04950322
A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study，the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.
Timeline
- Start
- 2021-12-06
- Primary completion
- 2024-05-20
- Completion
- 2025-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Retlirafusp alfa | Protein / enzyme biologic | — | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Oxaliplatin | Small molecule | — | — |