Actively Recruiting
Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
Led by The University of Hong Kong · Updated on 2025-12-26
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatocellular carcinoma (HCC) is a common and deadly cancer worldwide, especially in Asia where hepatitis B is widespread. Many patients are diagnosed at stages where surgery is not possible, and current curative treatments like surgery, radiofrequency ablation, or liver transplant only help about 30% of patients. This trial aims to explore a new combined approach using immunotherapy and targeted radiation to shrink tumors, potentially making inoperable HCC operable and improving survival chances. The study involves treating participants first with Stereotactic Body Radiation Therapy (SBRT), a precise form of external radiation aimed directly at the tumor. This is followed by immunotherapy drugs selected by oncologists. Treatment may continue for up to two years unless the disease improves enough for surgery, the treatment stops working, or side effects become unacceptable. The main goal is to see how many patients can have their tumors downstaged to be eligible for surgery. Participants will be monitored throughout the study to assess tumor response and treatment effects. Researchers will measure the rate of tumor downstaging at the time patients become eligible for surgery. The study includes regular assessments using imaging and clinical evaluations to track progress. The total study duration may last up to two years or until surgery is possible. Safety and treatment tolerability will also be closely followed during this period.
CONDITIONS
Brief Title
Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hepatocellular carcinoma (HCC) based on American Association for the Study of Liver Diseases guidelines with liver nodules >1 cm showing specific imaging features
- Tumor size between 5 and 25 cm or up to 3 lesions or segmental portal vein involvement
- Age between 18 and 80 years old
- Child Pugh liver function class A to B7
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Prior invasive cancer
- Prior radiotherapy to liver region or selective internal radiotherapy
- Severe, active other medical conditions
- Presence of cancer spread outside the liver (extra-hepatic metastases)
- Main portal vein or inferior vena cava thrombosis or involvement
- Presence of ascites or encephalopathy
- Contraindications to stereotactic body radiation therapy (SBRT) including any HCC tumor >15 cm, total tumor size over 25 cm, more than 3 discrete liver nodules, or tumor extension into stomach, intestines, or major bile ducts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years or until disease is amendable to surgery or unacceptable toxicity
Participants receive Stereotactic Body Radiation Therapy followed by immunotherapy. Immunotherapy lasts for up to 2 years unless it is no longer effective, causes unacceptable side effects, or the disease can be surgically removed.
Trial Site Locations
Total: 1 location
1
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
A
Albert Chan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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