Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT04947956
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    The camrelizumab-based treatment will be determined by the investigator.

Study Details

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.

Key Dates

Start date
Sep 1, 2021
Status verified
Jun 2021
Primary completion
Sep 1, 2023
Completion
Sep 1, 2025

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

The incidence of treatment-emergent adverse events (TEAE) [ Time Frame: Up to ~2 years ]

Central Contacts

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