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

Primary Purpose

Hepatocellular Carcinoma Non-Resectable

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-Resectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • The Second Hospital of Anhui Medical University
  • Cancer Hospital Chinese Academy of Medical Science
  • Fujian Medical University Union Hospital
  • Guangdong General Hospital
  • Cancer Hospital of Shantou University Medical College
  • Haerbin Medical University Cancer Hospital
  • Xiangya Hospital Central South University
  • Hunan Cancer Hospital
  • 81 Hospital Nanjing
  • The First Affiliated Hospital of Nanchang University
  • Jilin Cancer Hospital
  • Zhangshan Hospital Fudan University
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • West China Hospital
  • The First Affiliated Hospital Zhejiang University
  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SHR-1210 Q2W

SHR-1210 Q3W

Arm Description

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks

Outcomes

Primary Outcome Measures

Objective Response Rate per RECIST 1.1
Overall Survival Rate at 6-month

Secondary Outcome Measures

Duration of Response Rate per RECIST 1.1
Number of Subjects with one or more adverse events as assessed by CTCAE 4.0
Overall Survival

Full Information

First Posted
November 22, 2016
Last Updated
December 24, 2017
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02989922
Brief Title
A Study to Evaluate SHR-1210 in Subjects With Advanced HCC
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Non-Resectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHR-1210 Q2W
Arm Type
Experimental
Arm Description
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
Arm Title
SHR-1210 Q3W
Arm Type
Experimental
Arm Description
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks
Intervention Type
Biological
Intervention Name(s)
SHR-1210
Intervention Description
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Primary Outcome Measure Information:
Title
Objective Response Rate per RECIST 1.1
Time Frame
Up to approximately 6 months
Title
Overall Survival Rate at 6-month
Time Frame
Up to approximately 6 months
Secondary Outcome Measure Information:
Title
Duration of Response Rate per RECIST 1.1
Time Frame
Up to approximately 2 years
Title
Number of Subjects with one or more adverse events as assessed by CTCAE 4.0
Time Frame
Up to approximately 2 years
Title
Overall Survival
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Haerbin Medical University Cancer Hospital
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
81 Hospital Nanjing
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Zhangshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35101942
Citation
Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1):e003133. doi: 10.1136/jitc-2021-003133.
Results Reference
derived
PubMed Identifier
32112738
Citation
Qin S, Ren Z, Meng Z, Chen Z, Chai X, Xiong J, Bai Y, Yang L, Zhu H, Fang W, Lin X, Chen X, Li E, Wang L, Chen C, Zou J. Camrelizumab in patients with previously treated advanced hepatocellular carcinoma: a multicentre, open-label, parallel-group, randomised, phase 2 trial. Lancet Oncol. 2020 Apr;21(4):571-580. doi: 10.1016/S1470-2045(20)30011-5. Epub 2020 Feb 26.
Results Reference
derived

Learn more about this trial

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

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