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

Jiangsu HengRui Medicine Co., Ltd.220 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Hepatocellular Carcinoma Non-Resectable

Interventions

SHR-1210BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Outcomes

Primary Outcomes

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).

Time frame: approximate 3 years

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)

Time frame: from the date of the first dose to 6 months

Secondary Outcomes

Duration of Response

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

Time frame: approximate 3 years

Adverse Events

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

Time frame: approximate 3 years

Overall Survival

Time from first dose to death from any cause

Time frame: approximate 3 years

Data from ClinicalTrials.gov

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