RT+ Anti-PD-1 for Patients With Advanced HCC (RT+PD-1-HCC)

Study Overview
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Brief Summary
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Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Approximately 70-80% of newly diagnosed HCC patients already have advanced disease. Sorafenib and lenvatinib are recommended as first-line options for advanced HCC, the median overall survival of the patients with advanced HCC receiving sorafenib reached 10.7 months. Based on the results of phase II clinical studies and the recommendation of guidelines, the PD-1 monoclonal antibody, such as nivolumab and pembrolizumab, have been approved to treat the patients with advanced HCC by the FDA. PD-1 monoclonal antibody has been recommended as a second-line therapeutic strategy for HCC in the 2018 CSCO guidelines for the diagnosis and treatment of primary liver cancer. However, the results of existing studies indicate that the objective response rate (ORR) of first-line PD-1 antibody therapy for patients with advanced liver cancer is about 20%. There is a growing recognition of radiation-induced cancer cells-external tumor control mechanisms, in which radiation therapy(RT) contributes not only to local control of target lesions, but also to the control of metastases away from the treatment site. In recent years, RT combined with immunotherapy as a new treatment method has achieved certain curative effect in some patients with metastatic cancer. Therefore, it is interesting to investigate the efficacy of combining radiation therapy plus systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma.

Official Title
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Combining Radiation Therapy With Anti-PD-1 for Patients With Advanced Hepatocellular Carcinoma (RT+PD-1-HCC)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Radiation therapy and systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years Diagnosis of advanced HCC was confirmed by histopathological examination or clinical diagnosis, consistent with the following two conditions: Extrahepatic metastasis with more than one measurable lesion; Intrahepatic multifocal lesions with more than one measurable lesion independent of the radiosurgery field Patients have Child-Pugh A liver function Expected survival ≥ 3 months Unwilling to receive or unable to tolerate first-line treatment with sorafenib Exclusion Criteria: History of other malignancy History of systemic immunotherapy History of Radiation therapy within 6 months before the first administration History of active autoimmune diseases requiring systemic treatment within 2 years before recruiting. There are active infections that require systemic treatment Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study Pregnant or breast-feeding patients Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: This stuy has only one arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiotherapy plus PD-1<br> | Drug: Radiation therapy and systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma<br>* The treatment will be started within 1 week after being admitted into the trial. IMRT or SBRT are adopted , and dose of radiation: Dt-PGTV=40Gy/10fractions,Dt-PGTV=30Gy/10fractions,Dt-PGTV=20Gy/10fractions ,and so on.200mg/ of Carelizumab for injection will be given intravenously every 3 weeks for 5 times since the first day of radiotherapy until disease progression, or intolerable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 
| Abscopal effects rate |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced HCC, anti-PD-1, radiotherapy