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A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC

NCT03764293 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 543

Last updated 2024-02-06

Study results available
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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.

Conditions

  • Locally Advanced or Metastatic and Unresectable HCC

Interventions

DRUG

SHR-1210

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

DRUG

Apatinib

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

DRUG

Sorafenib

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shukui Qin, MD · Eastern Theater General Hospital,QinHuai District Medical Area

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2022-02-08
Completion
2023-06-14
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • China
  • Germany
  • Hong Kong
  • Italy
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764293 on ClinicalTrials.gov