NCT04947956

Brief Summary

Primary liver cancer is the second most common cause of cancer death in China, and hepatocellular carcinoma (HCC) represents more than 80% of liver cancer cases. The majority of HCC cases present at an advanced stage, and are thus not amenable to surgery. Immunotherapies, including PD-1 and PD-L1 inhibitors, alone or combined with other regimens, have shown encouraging clinical activity in unresectable HCC. Camrelizumab, a humanised monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1 and consequently inhibit the immune escape of tumour cells， which has been approved for the second-line treatment of advanced HCC. This observational study aims to evaluate the safety and efficacy of camrelizumab in Chinese unresectable HCC in the real world.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • The incidence of treatment-emergent adverse events (TEAE)

    The incidence of treatment-emergent adverse events (TEAE)

    Up to ~2 years

Secondary Outcomes (3)

  • Overall survival

    Up to ~2 years

  • Progression-free survival

    Up to ~2 years

  • Time to progression

    Up to ~2 years

Interventions

CamrelizumabDRUG

The camrelizumab-based treatment will be determined by the investigator.

Also known as: Apatinib, TACE, Radiotherapy, et al

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Unresectable hepatocellular carcinoma

You may qualify if:

  • \. Volunteer to participate in this study and sign an informed consent form; 2. Age ≥ 18 years; 3. Hepatocellular carcinoma confirmed/clinically confirmed by histopathology, cytology or imaging

You may not qualify if:

  • \. Documented pregnant or breastfeeding women;
  • \. Patients who are participating in any interventional trials beyond clinical practice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 32112738BACKGROUND

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PMID: 26808342BACKGROUND

  • Mo H, Huang J, Xu J, Chen X, Wu D, Qu D, Wang X, Lan B, Wang X, Xu J, Zhang H, Chi Y, Yang Q, Xu B. Safety, anti-tumour activity, and pharmacokinetics of fixed-dose SHR-1210, an anti-PD-1 antibody in advanced solid tumours: a dose-escalation, phase 1 study. Br J Cancer. 2018 Aug;119(5):538-545. doi: 10.1038/s41416-018-0100-3. Epub 2018 May 14.

    PMID: 29755117BACKGROUND

  • Huang J, Xu B, Mo H, Zhang W, Chen X, Wu D, Qu D, Wang X, Lan B, Yang B, Wang P, Zhang H, Yang Q, Jiao Y. Safety, Activity, and Biomarkers of SHR-1210, an Anti-PD-1 Antibody, for Patients with Advanced Esophageal Carcinoma. Clin Cancer Res. 2018 Mar 15;24(6):1296-1304. doi: 10.1158/1078-0432.CCR-17-2439. Epub 2018 Jan 22.

    PMID: 29358502BACKGROUND

  • Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.

    PMID: 33087333BACKGROUND

MeSH Terms

Interventions

camrelizumabapatinibRadiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jian Zhou, Doctor

CONTACT

13801914007zhou.jian@zs-hospital.sh.cn

Jie Hu, Doctor

CONTACT

15821405191hu.jie3@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 1, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2025

Last Updated

July 1, 2021

Record last verified: 2021-06