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

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ClinicalTrials.gov Identifier: NCT02989922
Recruitment Status : Active, not recruiting
First Posted : December 12, 2016
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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 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 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

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



Primary Outcome Measures :
  1. Objective Response Rate per RECIST 1.1 [ Time Frame: Up to approximately 6 months ]
  2. Overall Survival Rate at 6-month [ Time Frame: Up to approximately 6 months ]

Secondary Outcome Measures :
  1. Duration of Response Rate per RECIST 1.1 [ Time Frame: Up to approximately 2 years ]
  2. Number of Subjects with one or more adverse events as assessed by CTCAE 4.0 [ Time Frame: Up to approximately 2 years ]
  3. Overall Survival [ Time Frame: Up to approximately 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
China, Anhui
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
China, Beijing
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing, China, 100021
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515041
China, Heilongjiang
Haerbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China, 150040
China, Hunan
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
China, Jiangsu
81 Hospital Nanjing
Nanjing, Jiangsu, China, 210002
China, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
China, Shanghai
Zhangshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
China, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi, China, 710061
China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610041
China, Zhejiang
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China, 310003
China
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02989922     History of Changes
Other Study ID Numbers: SHR-1210-II/III-HCC
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Additional relevant 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