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Completed

NCT Number: NCT02989922

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Non-resectable

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
  • Failed or intolerable to at least one prior systemic treatment for advanced HCC
  • ECOG Performance Status of 0 or1
  • Child-Pugh Class A or B with 7 points
  • Life Expectancy of at least 12 weeks
  • HBV DNA<500 IU/ml
  • Adequate organ function
  • 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

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Known liver transplant or plan to transplant
  • GI hemorrhage with 6 months
  • History or current brain metastases
  • Active known, or suspected autoimmune disease

Treatment and study plan

SHR-1210

Biological

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Primary outcomes

  1. 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).

  2. 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 outcomes

  1. Duration of Response

    Time frame: approximate 3 years

    time from first response to progression or death base on the IRC assessment

  2. Adverse Events

    Time frame: approximate 3 years

    Number of Subjects with one or more adverse events as assessed by CTCAE 4.03

  3. Overall Survival

    Time frame: approximate 3 years

    Time from first dose to death from any cause

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2016
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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