At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 220 enrolled
Drug / intervention
SHR-1210biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SHR-1210 for Hepatocellular Carcinoma Non-Resectable. Completed, enrolled 220 participants across 17 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma Non-Resectable
CountriesChina
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedDec 2016
Primary CompletionMar 2020
TodayJul 2026
First PostedDec 12, 2016
Enrollment StartNov 15, 2016
Primary CompletionMar 3, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.6 years ago
Interventions
SHR-1210biological
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody