NCT02989922

A Study to Evaluate SHR-1210 in Subjects With Advanced HCC

A Randomized Controlled Multicentered Phase 2/3 Study to Evaluate SHR-1210 (PD-1 Antibody) in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Failed or Intolerable to Prior Systemic Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210 in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and Overall Survival when compare with SOC.

Detailed description

In June 2017, this study was revised to expand the Phase 2 part to enroll more subjects and remove the Phase 3 part under the same protocol. A Phase 3 study will be initiated separately.

Conditions

• Hepatocellular Carcinoma Non-Resectable

Interventions

Type	Name	Description
BIOLOGICAL	SHR-1210	SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Timeline

• Start date: 2016-11-15
• Primary completion: 2020-03-03
• Completion: 2020-03-03
• First posted: 2016-12-12
• Last updated: 2024-03-15
• Results posted: 2024-03-15

Locations

17 sites across 1 country: China