drugset / Trial / NCT03603756

SHR-1210 in Combination With Apatinib and Chemotherapy in Patients With Advanced Esophageal Squamous Cell Cancer

NCT03603756

Phase 2 Unknown 45 enrolled Chinese Academy of Medical Sciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma are recruited to this prospective non-randomized study comprising two separate cohorts. Patients will receive SHR-1210, a novel anti-PD-1 antibody, with apatinib and either irinotecan or paclitaxel liposome plus nedaplatin. The primary endpoint is to determine the objective response rate (ORR) of patients in both cohorts. The regimen(s) of promising efficacy will be further verified in subsequent randomized studies to define the optimal combination of immunotherapy, anti-angiogenesis and chemotherapy in advanced esophageal cancer patients.

Timeline

Start
2018-07-31
Primary completion
2020-03-28
Completion
2021-03-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg
Subject Irinotecan Small molecule
Subject Nedaplatin Small molecule 50 mg/m2
Subject Paclitaxel Small molecule 150 mg/m2
Subject Rivoceranib Small molecule 250 mg