drugset / Trial / NCT04486651

HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

NCT04486651

Phase 3 Unknown 560 enrolled Taizhou Hanzhong Biomedical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine therapy.

Timeline

Start
2020-09-16
Primary completion
2023-08-10
Completion
2023-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Pucotenlimab Monoclonal antibody 200 mg Intravenous
Background Irinotecan Small molecule 160 mg/m2 Intravenous

Indications