drugset / Trial / NCT02008422

Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer

NCT02008422

Phase 3 Unknown 120 enrolled Tang Xushan
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives of this control, single-center clinical study of EndostarTM Injection with/without SOX protocols to treat advanced gastric cancer were to evaluate the clinical response rate of Endostar injection concomitant with SOX on patients with advanced gastric cancer, observe the progression-free survival time (PFS) of tumor and evaluate the safety and tolerance of Endostar injection, while the secondary objectives were to observe the influence of Endostar injection on chemotherapy-induced adverse reactions and evaluate the overall survival time of EndostarTM injection concomitant with SOX on patients with advanced gastric cancer by evaluating the response rate (RR) clinical benefit rate (CBR), progression-free survival (PFS) and overall survival (OS).

Timeline

Start
2013-08
Primary completion
2016-05
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Endostar Protein / enzyme biologic 7.5 mg/m2 Intravenous
Background Gimeracil and Oteracil Potassium Unknown 40 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications