Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma

Peking University Cancer Hospital & Institute1 site in 1 country39 target enrollmentJune 2023

ConditionsUnresectable Hepatocellular Carcinoma Oligometastatic Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Unresectable Hepatocellular Carcinoma
Sponsor: Peking University Cancer Hospital & Institute
Enrollment: 39
Locations: 1
Primary Endpoint: PFS
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this phase 2 prospective clinical trial is to learn about the efficacy and safety of stereotactic body radiation therapy (SBRT) plus immunotherapy and targeted therapy in patients with unresectable or oligometastatic hepatocellular carcinoma (HCC).

The main question to answer is: Whether combing SBRT with immunotherapy and targeted therapy could prolong PFS. Participants will receive SBRT to all visible lesions and concurrent systemic immunotherapy and targeted therapy.

Registry

clinicaltrials.gov

Start Date

June 2023

End Date

December 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University Cancer Hospital & Institute

Responsible Party

Principal Investigator

Wang weihu

Professor

Peking University Cancer Hospital & Institute

Eligibility Criteria

Inclusion Criteria

•age ≥ 18 years
•Eastern Cooperative Oncology Group performance status of 0-1
•clinical or pathological diagnosis of HCC
•with unresectable locally advanced or oligometastatic HCC (metastatic lesions ≤ 5, metastatic organs ≤ 3, may involve extrahepatic lymph nodes or distant organs apart from brain)
•at least one measurable lesion according to mRECIST criteria
•all lesions could be included in radiation target volume
•Child-Pugh A or B (7 scores) liver function
•patients are allowed to receive systemic therapy previously other than tislelizumab plus regorafenib
•adequate hematological and renal function
•life expectancy ≥ 3 months；

Exclusion Criteria

•a history of liver transplantation
•with severe cirrhosis complications, including a history of esophagogastric variceal bleeding, hepatic encephalopathy, and massive ascites
•with active autoimmune diseases or a history of autoimmune disease
•with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
•allergic to the ingredient of tislelizumab or regorafenib
•with recurrent lesions treated with radiotherapy previously
•prescribed radiation does could not be delivered due to dose limits to organs at risk (OAR)
•intolerable to radiation or systemic treatment because of cardiac insufficiency, uncontrolled high blood pressure
•a history of other malignancies, except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Outcomes

Primary Outcomes

PFS

Time Frame: From the date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Progression-free survival

Secondary Outcomes

OS(From the date of treatment beginning until the date of death from any cause, assessed up to 48 months)
Recurrence pattern(From the date of treatment beginning until the date of last follow-up, assessed up to 48 months)