A Study to Evaluate SHR-1210 in Subjects With Advanced HCC
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
1 other identifier
interventional
220
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2016
CompletedFirst Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
December 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2020
CompletedResults Posted
Study results publicly available
March 15, 2024
CompletedMarch 15, 2024
December 1, 2017
3.3 years
November 22, 2016
July 3, 2020
March 14, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
Duration of Response
approximate 3 years
Adverse Events
approximate 3 years
Overall Survival
approximate 3 years
Study Arms (2)
SHR-1210 Q2W
EXPERIMENTALSubjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
SHR-1210 Q3W
EXPERIMENTALSubjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Haerbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150040, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
81 Hospital Nanjing
Nanjing, Jiangsu, 210002, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Zhangshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
West China Hospital
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, 310003, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Related Publications (3)
Zhou X, Cao J, Topatana W, Xie T, Chen T, Hu J, Li S, Juengpanic S, Lu Z, Zhang B, Wang K, Feng X, Shen J, Chen M. Evaluation of PD-L1 as a biomarker for immunotherapy for hepatocellular carcinoma: systematic review and meta-analysis. Immunotherapy. 2023 Apr;15(5):353-365. doi: 10.2217/imt-2022-0168. Epub 2023 Feb 27.
PMID: 36852452DERIVEDShi 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.
PMID: 35101942DERIVEDQin 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.
PMID: 32112738DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Linna Wang
- Organization
- Jiangsu HengRui Pharmaceuticals Co., Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2016
First Posted
December 12, 2016
Study Start
November 15, 2016
Primary Completion
March 3, 2020
Study Completion
March 3, 2020
Last Updated
March 15, 2024
Results First Posted
March 15, 2024
Record last verified: 2017-12