This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02989922
Recruitment Status : Completed
First Posted : December 12, 2016
Results First Posted : March 15, 2024
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Non-Resectable Biological: SHR-1210 Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : March 3, 2020
Actual Study Completion Date : March 3, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SHR-1210 Q2W
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
 Biological: SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Experimental: SHR-1210 Q3W
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks
 Biological: SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989922


Locations
Show Show 17 study locations
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
  Study Documents (Full-Text)

Documents provided by Jiangsu HengRui Medicine Co., Ltd.:
Study Protocol  [PDF] April 3, 2018
Statistical Analysis Plan  [PDF] January 8, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02989922    
Other Study ID Numbers: SHR-1210-II/III-HCC
First Posted: December 12, 2016    Key Record Dates
Results First Posted: March 15, 2024
Last Update Posted: March 15, 2024
Last Verified: December 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases