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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03764293
Phase
PHASE3
Status
Completed

Conditions

  • Locally Advanced or Metastatic and Unresectable HCC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210 — DRUG
    Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
  • Apatinib — DRUG
    Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet
  • Sorafenib — DRUG
    Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet

Study Details

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.

Key Dates

Start date
Jun 10, 2019
Status verified
Feb 2023
Primary completion
Feb 8, 2022
Completion
Jun 14, 2023

Study Design

Enrollment
543 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-1210
    SHR-1210+Apatinib
  • Active Comparator: Control
    Sorafenib

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
University of California San Diego (UCSD)-Moores Cancer CenterLa JollaCalifornia92037-
University of California - IrvineOrangeCalifornia92868-
University of MarylandBaltimoreMaryland21201-
Cornell University Weill Cornell Medical CollegeNew YorkNew York10065-
The Center for Cancer and Blood DisordersFort WorthTexas76104-
MD Anderson Cancer CenterHoustonTexas77030-
Renovatio ClinicalThe WoodlandsTexas77380-

Find similar trials in Beverly Hills, CA

By research site
Beverly Hills Cancer Center· Beverly Hills, CAUniversity of California San Diego (UCSD)-Moores Cancer Center· La Jolla, CAUniversity of California - Irvine· Orange, CAUniversity of Maryland· Baltimore, MDCornell University Weill Cornell Medical College· New York, NYThe Center for Cancer and Blood Disorders· Fort Worth, TX