NCT05917431

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unresectable Hepatocellular Carcinoma
• Oligometastatic Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SBRT plus tislelizumab and regorafenib	Participants will receive SBRT plus tislelizumab and regorafenib concurrently

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2023-06-23
• Last updated: 2023-06-23

Locations

1 site across 1 country: China