Clinical trial NCT04947956: Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma
Official title: Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma in China: a Real-world Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Unresectable Hepatocellular Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of treatment-emergent adverse events (TEAE)
timeFrame: Up to ~2 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to ~2 years
measure: Progression-free survival
timeFrame: Up to ~2 years
measure: Time to progression
timeFrame: Up to ~2 years
Other outcomes:
Locations:
Study officials:
References:
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