NCT05917431 Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC

Trial Parameters

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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.

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

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