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Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma

Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma in China: a Real-world Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04947956
Enrollment
1000
Registered
2021-07-01
Start date
2021-09-01
Completion date
2025-09-01
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Hepatocellular Carcinoma

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.

Detailed description

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 multi-center, open-label, observational study aims to evaluate the safety and efficacy of camrelizumab in Chinese unresectable HCC in the real world. This study also aims to evaluate the treatment of camrelizumab in subgroups, to provide information of treatment regimens and efficacy in clinical practice. The anticipated sample size is 1000, and the camrelizumab-based treatment will be determined by the investigator.

Interventions

DRUGCamrelizumab

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

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 1\. 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

Exclusion criteria

* 1\. Documented pregnant or breastfeeding women; * 2\. Patients who are participating in any interventional trials beyond clinical practice.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of treatment-emergent adverse events (TEAE)Up to ~2 yearsThe incidence of treatment-emergent adverse events (TEAE)

Secondary

MeasureTime frameDescription
Overall survivalUp to ~2 yearsOverall survival
Progression-free survivalUp to ~2 yearsProgression-free survival
Time to progressionUp to ~2 yearsTime to progression

Contacts

Primary ContactJian Zhou, Doctor
zhou.jian@zs-hospital.sh.cn13801914007
Backup ContactJie Hu, Doctor
hu.jie3@zs-hospital.sh.cn15821405191

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026