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

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Radiation therapy and systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma

• Registration Number: NCT04193696
• Lead Sponsor: Guangxi Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09
• Study Start: 2020-01-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiotherapy plus PD-1	Radiation therapy and systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	6 months

Secondary Outcome Measures

Name	Time	Method
Abscopal effects rate	6 months
Overall survival	1 year