Camrelizumab Utilization on Patients With Advanced Liver Cancer

Study Overview
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Brief Summary
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To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer

Detailed Description
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camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of circulating T lymphocytes, and binds to epitopes different from Nivolumab and pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for indication for advanced hepatocellular carcinoma The main objective of this study was to observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab in advanced liver cancer。 The subjects included people over 18 years old， For men and women with advanced liver cancer confirmed by histopathology or cytology;

Official Title
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A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer

Conditions
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Advanced Hepatocellular Carcinoma

Intervention / Treatment
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* Other: camrelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or more; For both men and women; Patients with advanced liver cancer confirmed by histopathology or cytology; .Volunteer to join the study, sign the informed consent, good compliance, and cooperate with the follow-up. Exclusion Criteria: A known allergy to the study drug or any of its excipients; Or had a severe allergic reaction to other monoclonal antibodies; Patients who are ready for or have previously received an organ or allogeneic bone marrow transplant; Pregnant or lactating women; According to the judgment of the researcher, the patients should not be included in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Camrelizumab in the treatment of liver cancer<br>Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min | Other: camrelizumab<br>* camrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, one cycle every 2 weeks (14 days) or one cycle every 3 weeks (21 days). Try to complete the administration before the ECG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Safety as defined by the NCI CTCAE v5.0 | Adverse events as graded by CTCAE v5.0 | From patients participate in the clinical study to 90 days after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | 1-year, 3-year, 5-year survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RWS, Advanced Liver Cancer, PD-1