Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Jun 15, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment approach for patients with unresectable hepatocellular carcinoma (HCC), which means the cancer cannot be surgically removed, or those with a limited number of metastatic lesions (cancer that has spread). The study aims to see if combining stereotactic body radiation therapy (SBRT) with two types of medication—an immunotherapy called tislelizumab and a targeted therapy called regorafenib—can help patients live longer without their disease getting worse.

To be eligible for this trial, participants must be at least 18 years old and have a specific type of HCC that meets certain criteria, such as having at least one measurable tumor. They should also have good liver function and be in decent overall health. During the trial, participants will receive targeted radiation to their tumors along with the two medications. This study is currently seeking volunteers, and patients who join will be closely monitored to assess the safety and effectiveness of this treatment combination.

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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；
• • willing to participate in the study and give written informed consent
• 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