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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 3, 2020

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.

Interventions

  • Biological: SHR-1210
    • SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Arms, Groups and Cohorts

  • Experimental: SHR-1210 Q2W
    • Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
  • Experimental: SHR-1210 Q3W
    • Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Objective Response Rate
    • Time Frame: approximate 3 years
    • Tumour responses were evaluated by the independent review committee (IRC) according to RECIST 1.1.The primary endpoints were the proportion of patients with a IRC-assessed objective response (defined as the percentage of patients whose best overall response was confirmed complete or partial response).
  • 6-month Overall Survival Rate
    • Time Frame: from the date of the first dose to 6 months
    • 6-month overall survival rate (defined as cumulative overall survival rate from the date of the first dose to 6 months)

Secondary Measures

  • Duration of Response
    • Time Frame: approximate 3 years
    • time from first response to progression or death base on the IRC assessment
  • Adverse Events
    • Time Frame: approximate 3 years
    • Number of Subjects with one or more adverse events as assessed by CTCAE 4.03
  • Overall Survival
    • Time Frame: approximate 3 years
    • Time from first dose to death from any cause

Participating in This Clinical Trial

Inclusion Criteria

1. Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1 2. Failed or intolerable to at least one prior systemic treatment for advanced HCC 3. ECOG Performance Status of 0 or1 4. Child-Pugh Class A or B with 7 points 5. Life Expectancy of at least 12 weeks 6. HBV DNA<500 IU/ml 7. Adequate organ function 8. Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC 2. Known liver transplant or plan to transplant 3. GI hemorrhage with 6 months 4. History or current brain metastases 5. Active known, or suspected autoimmune disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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