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

Guangxi Medical University

Status and phase

Unknown

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04193696

RT+PD-1-HCC

Details and patient eligibility

About

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.

Enrollment

39 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18-70 years
Diagnosis of advanced HCC was confirmed by histopathological examination or clinical diagnosis, consistent with the following two conditions:
1. Extrahepatic metastasis with more than one measurable lesion;
2. 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.