CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 543 enrolled
Drug / intervention
SHR-1210 +2 moredrug
Likely dose
SHR-1210 200 mgfrom 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.

Search/NCT03764293
NCT03764293Phase 3Completed

A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy

Jiangsu HengRui Medicine Co., Ltd.·interventional·Posted Dec 5, 2018·Updated Feb 6, 2024

In Brief

A Phase 3 clinical trial evaluating SHR-1210, Apatinib, and 1 other intervention for Locally Advanced or Metastatic and Unresectable HCC. Completed, enrolled 543 participants across 121 sites in 13 countries.

Detailed Summary

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, China, Germany, Hong Kong, Italy, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 5, 2018
Enrollment StartJun 10, 2019
Primary CompletionFeb 8, 2022
Study CompletionJun 14, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.6 years ago

Interventions

SHR-1210drug

Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial

Apatinibdrug

Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet

Sorafenibdrug

Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet