Combined immunotherapy and stereotactic radiotherapy to shrink unresectable liver cancer for possible surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional study delivers stereotactic body radiation therapy (SBRT) to liver tumors followed by systemic immunotherapy, with regular imaging to track tumor response. Eligible adults with unresectable HCC, limited tumor burden, Child‑Pugh A–B7 liver function and ECOG 0–1 will receive a defined SBRT course and subsequent immunotherapy per protocol. The primary goal is downstaging tumors to enable surgical resection; secondary outcomes include safety, changes in liver function, and progression-related measures. The work is conducted at Queen Mary Hospital (The University of Hong Kong) as an exploratory, proof-of-concept effort.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of HCC is made according to American Association for the Study of Liver Diseases (AASLD) practice guideline 2010: patients with cirrhosis of any etiology and patients with chronic hepatitis B (HBV) who may not have fully developed cirrhosis, the presence of liver nodule \>1cm and demonstrated in a single contrast enhanced dynamic imaging \[either computed tomography (CT) or magnetic resonance imaging (MRI)\] of intense arterial uptake and "washout" in portal venous and delayed phases.
* Tumor size 5-25 cm or number of lesions ≤3 or segmental portal vein involvement
* Age: 18-80 years old
* Child Pugh liver function class A-B7
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Prior invasive malignancy
* Prior radiotherapy to the region of liver or selective internal radiotherapy
* Severe, active co-morbidity
* Presence of extra-hepatic metastases (M1)
* Main portal vein or inferior vena cava (IVC) thrombosis or involvement
* Presence of ascites or encephalopathy
* Contraindicated of SBRT:

  * Any one hepatocellular carcinoma \> 15 cm
  * Total maximal sum of hepatocellular carcinoma \> 25 cm
  * More than 3 discrete hepatic nodule
  * Direct tumor extension into the stomach, duodenum, small bowel, large bowel, common or main branch of biliary tree

Where it's running

• Queen Mary Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Albert Chan
• Email: hbptrial@hku.hk
• Phone: +852 2255 6646

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.