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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in China

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.

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 groups in NCT02989922
Study groupRoleWhat they receive
SHR-1210 Q2WExperimentalSubjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
Receives: Biological: SHR-1210
SHR-1210 Q3WExperimentalSubjects 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.

  1. 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

  2. 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)

  1. Duration of Response

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

    Measured: approximate 3 years

  2. Adverse Events

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

    Measured: approximate 3 years

  3. 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.

  1. First posted12 Dec 2016 (estimated)
  2. Study start15 Nov 2016
  3. Primary completion3 Mar 2020
  4. Study completion3 Mar 2020

Resources

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)
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
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 36852452

  • Shi 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 35101942

  • Qin 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: approximate 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02989922, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

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