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

Hepatocellular Carcinoma Non-Resectable Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989922
• Other study ID #: SHR-1210-II/III-HCC
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2016
• Est. completion date: March 3, 2020

Study information

• Verified date: December 2017
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-Resectable

Intervention

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

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital	Chengdu	Sichuan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Haerbin Medical University Cancer Hospital	Haerbin	Heilongjiang
China	The First Affiliated Hospital Zhejiang University	Hangzhou	Zhejiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	81 Hospital Nanjing	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai
China	Zhangshan Hospital Fudan University	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	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).	approximate 3 years
Primary	6-month Overall Survival Rate	6-month overall survival rate (defined as cumulative overall survival rate from the date of the first dose to 6 months)	from the date of the first dose to 6 months
Secondary	Duration of Response	time from first response to progression or death base on the IRC assessment	approximate 3 years
Secondary	Adverse Events	Number of Subjects with one or more adverse events as assessed by CTCAE 4.03	approximate 3 years
Secondary	Overall Survival	Time from first dose to death from any cause	approximate 3 years