Using SBRT for patients with limited progression of liver cancer on immunotherapy

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 study evaluates the efficacy and safety of adding Stereotactic Body Radiation Therapy (SBRT) to patients with hepatocellular carcinoma (HCC) who have experienced oligoprogression while on the immunotherapy combination of atezolizumab and bevacizumab. It focuses on patients with limited progression, defined as having three or fewer lesions, and aims to determine if SBRT can prolong the effectiveness of systemic therapy. The study is prospective and single-arm, meaning all participants will receive the same treatment without a control group. The research is particularly relevant given the high incidence and mortality rates of HCC in Hong Kong.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged ≥ 18 years old
2. ECOG performance 0 to 1
3. Confirmed diagnosis of HCC
4. Oligoprogression on first-line immunotherapy, as defined as ≤ 5 lesions (intra- and extrahepatic lesions all together; vascular tumor thrombus is counted as one lesion)

   * First-line immunotherapy that are allowed in this study include atezolizumab plus bevacizumab, durvalumab plus tremelimumab, durvalumab, nivolumab and ipilimumab, which are approved by the FDA and have been used in Hong Kong.
5. Progressed lesion(s) amenable to SBRT:

   * For intrahepatic progression:

     * Number of intrahepatic progression ≤ 5
     * Total intrahepatic tumours ≤ 10
     * Maximum sum of HCC ≤ 20cm
     * Any one HCC ≤ 20cm
     * Normal liver volume minus intrahepatic GTV \> 700cc
     * Mean liver dose ≤ 15Gy
     * No measurable common or main branch biliary duct involvement
     * No direct tumor invasion into the stomach, duodenum, small bowel or large bowel
   * For extrahepatic progression:

     * Maximal tumor size ≤ 7cm
     * Respective dose constraints of organ at risks as listed on the UK 2022 Consensus on Normal Tissue Dose-Volume Constraints for Oligometastatic, Primary Lung and Hepatocellular Carcinoma Stereotactic Ablative Radiotherapy can be met and ASTRO guideline.
6. Prior radiofrequency ablation (RFA) or trans-arterial chemoembolization (TACE) are eligible
7. Child-Pugh A liver function
8. Life expectancy longer than 12 weeks
9. At least one measurable treatment lesion according to RECIST 1.1
10. Written informed consent must be obtained prior to any study related procedures
11. Adequate haematological function (Hb ≥ 8.5g/dL; Plt ≥ 50x10\^9/L; ANC ≥ 1.0x10\^9/L; INR ≤ 1.5)
12. Adequate hepatic function (albumin ≥ 28g/L; Bilirubin ≤ 2.5xULN; ALT \< 5 times upper limit normal)
13. Adequate renal function (serum creatinine ≤ 1.5 times the upper limit of normal range; Na ≥ 130mmol/L; K ≥ 3.0mmol/L)
14. Able to read, understand and provide written consent

Exclusion Criteria:

1. History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years
2. Previous radiotherapy to the abdomen
3. Previous yttrium-90 chemoembolization
4. Repetitive history of non-healing wounds or ulcers within 2 months of inclusion
5. Pregnant or lactating females at any time during the study
6. Active autoimmune disease requiring systemic therapy in the past 2 years
7. Diagnosis of immunodeficiency (including HIV)
8. Ongoing corticosteroid therapy \>10mg prednisone daily

Where it's running

• Department of Clinical Oncology, Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Landon L CHAN, MBChB, MSc
• Email: landon.chan@cuhk.edu.hk
• Phone: 3505 1042

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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.