Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06434480

SBRT in HCC With Oligoprogression on First-line Immunotherapy

Led by Chinese University of Hong Kong · Updated on 2026-03-04

30

Participants Needed

1

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

HCC is a huge healthcare burden in Hong Kong and is one of the top 5 cancers in terms of incidence and mortality in Hong Kong. Patients with advanced HCC are treated with immunotherapy-based as first-line treatment as a standard of care. At the moment, there is limited evidence to guide subsequent treatments after patients progressed on immunotherapy. Oligoprogression is a term used to describe patients who had limited progression (usually less than 3 sites) on systemic therapy, with the rest of the lesions controlled. Previous studies in non-HCCs have shown that addition of locoregional treatment (e.g. radiotherapy) may prolong the use of systemic therapy, resulting in improved survival, but this has been relatively unexplored for HCC. In this prospective, single-arm study, we aim to evaluate the treatment outcome, efficacy and safety of the addition of radiotherapy to oligoprogressive sites for patients who had limited progression on First-line Immunotherapy.

CONDITIONS

Official Title

SBRT in HCC With Oligoprogression on First-line Immunotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 6 18 years or older
  • ECOG performance status 0 to 1
  • Confirmed diagnosis of hepatocellular carcinoma (HCC)
  • Oligoprogression on first-line immunotherapy with 5 or fewer lesions total
  • First-line immunotherapy includes FDA-approved drugs used in Hong Kong such as atezolizumab plus bevacizumab, durvalumab plus tremelimumab, durvalumab, nivolumab, and ipilimumab
  • Progressed lesions suitable for SBRT:
    • For intrahepatic progression: 5 or fewer progressing lesions, total intrahepatic tumors 10 or fewer, maximum sum of HCC size 20 cm, any single HCC 20 cm or less, normal liver volume minus tumor greater than 700 cc, mean liver dose no more than 15 Gy, no major bile duct involvement, no tumor invasion into stomach, duodenum, small or large bowel
    • For extrahepatic progression: tumor size up to 7 cm, dose constraints per UK 2022 Consensus and ASTRO guidelines
  • Prior radiofrequency ablation or trans-arterial chemoembolization allowed
  • Child-Pugh A liver function
  • Life expectancy longer than 12 weeks
  • At least one measurable lesion by RECIST 1.1
  • Written informed consent provided
  • Adequate blood counts (Hb 6 8.5 g/dL, platelets 6 60x10^9/L, ANC 6 1.5x10^9/L, INR 4 1.5)
  • Adequate liver function (albumin 6 28 g/L, bilirubin 4 2.5 times upper limit, ALT less than 5 times upper limit)
  • Adequate kidney function (creatinine 4 1.5 times upper limit, sodium 6 130 mmol/L, potassium 6 3.0 mmol/L)
  • Able to read, understand, and provide written consent
Not Eligible

You will not qualify if you...

  • History of another cancer except treated basal cell carcinoma of skin or cervical intraepithelial neoplasia in last 5 years
  • Previous abdominal radiotherapy
  • Previous yttrium-90 chemoembolization
  • Repeated non-healing wounds or ulcers within 2 months before study
  • Pregnant or breastfeeding women
  • Active autoimmune disease needing systemic therapy in past 2 years
  • Immunodeficiency diagnosis including HIV
  • Ongoing corticosteroid therapy over 10 mg prednisone daily

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

L

Landon L CHAN, MBChB, MSc

CONTACT

N

Natalie KWONG, RN

CONTACT

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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