Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- SBRT plus tislelizumab and regorafenib
Treatment groups
39 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov