RecruitingPhase 2NCT05917431

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


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

39 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of SBRT (stereotactic body radiation therapy — highly precise, high-dose radiation), the immunotherapy drug tislelizumab, and a targeted therapy called regorafenib for people with liver cancer (HCC) that cannot be surgically removed or has spread to a small number of sites. **You may be eligible if...** - You are 18 or older - You have confirmed liver cancer (HCC) that is locally advanced or has spread to 5 or fewer sites in 3 or fewer organs - You have not had brain metastases - You have good performance status (ECOG 0–1) - You have adequate liver function **You may NOT be eligible if...** - Your cancer has spread to the brain - You have had prior immunotherapy or regorafenib - You have serious autoimmune disease - You have very poor liver function (Child-Pugh C) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTSBRT plus tislelizumab and regorafenib

Participants will receive SBRT plus tislelizumab and regorafenib concurrently


Locations(1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

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NCT05917431


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