Hepatocellular Carcinoma Non-ResectablePhase 2NCT02989922
A Study to Evaluate SHR-1210 in Subjects With Advanced HCC
A Phase 2 study testing SHR-1210 in people with Hepatocellular Carcinoma Non-Resectable, run by Jiangsu HengRui Medicine Co., Ltd. at 17 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma Non-Resectable
- What is being tested?
- SHR-1210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 17 sitesChina
- Study dates
- 15 Nov 2016to 3 Mar 2020
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Jilin Cancer Hospital
Changchun, Jilin, 130012
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Hunan Cancer Hospital
Changsha, Hunan, 410013
West China Hospital
Chengdu, Sichuan, 610041
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Haerbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150040
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, 310003
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
81 Hospital Nanjing
Nanjing, Jiangsu, 210002
Zhangshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Fudan University Shanghai Cancer Center
Shanghai, 200032
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
About this study
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
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma Non-Resectable
- Being tested
- SHR-1210
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Biological
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 Q2W | Experimental | Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks Receives: Biological: SHR-1210 |
| SHR-1210 Q3W | Experimental | Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 3 weeks Receives: Biological: SHR-1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: from the date of the first dose to 6 months
Secondary outcomes (3)
Duration of Response
time from first response to progression or death base on the IRC assessment
Measured: approximate 3 years
Adverse Events
Number of Subjects with one or more adverse events as assessed by CTCAE 4.03
Measured: approximate 3 years
Overall Survival
Time from first dose to death from any cause
Measured: approximate 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start15 Nov 2016
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma Non-ResectableStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989922
- Sponsor's protocol ID
- SHR-1210-II/III-HCC
- Status last verified
- Dec 2017
- First submitted
- 22 Nov 2016
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36852452Shi 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.
PubMed 35101942Qin 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.
PubMed 32112738