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

Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study

This project will test whether stereotactic body radiotherapy followed by immunotherapy can shrink unresectable hepatocellular carcinoma so surgery becomes possible for adults with preserved liver function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The University of Hong Kong (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Hong Kong)
• Trial ID: NCT07305428 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (18–80 years) with unresectable HCC meeting the size/number criteria (tumor 5–25 cm or ≤3 lesions or segmental portal vein involvement), Child‑Pugh A–B7 liver function, ECOG performance status 0–1, and no extrahepatic metastases.

Not a fit: Patients with extrahepatic metastases, main portal vein or IVC tumor thrombus, prior liver radiotherapy, severe active comorbidity, or poor liver function (e.g., Child‑Pugh C) are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could convert some inoperable liver cancers into resectable disease, increasing the chance of curative surgery and longer survival.

How similar studies have performed: Early studies and case series combining radiation and immunotherapy have shown promising tumor responses, but randomized evidence specifically proving reliable downstaging of unresectable HCC to resectability is limited, so this approach remains exploratory.

Eligibility criteria

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 this trial is running

Hong Kong

• Queen Mary Hospital — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Study coordinator: Albert Chan

Conditions: HCC - Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma