Using SBRT for patients with limited progression of liver cancer on immunotherapy
Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma With Oligoprogression on First-line Immunotherapy
This study is testing if adding a special type of radiation therapy can help people with liver cancer who have a few growing spots while on immunotherapy feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, durvalumab, tremelimumab, nivolumab, ipilimumab, immunotherapy, prednisone |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06434480 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of HCC and oligoprogression on atezolizumab plus bevacizumab.
Not a fit: Patients with extensive progression beyond three lesions or those with significant liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates for patients with advanced HCC who have limited progression on current immunotherapy treatments.
How similar studies have performed: Previous studies in other cancers have shown that adding locoregional treatments like radiotherapy can enhance systemic therapy outcomes, but this approach has been relatively unexplored in HCC.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥ 60x10\^9/L; ANC ≥ 1.5x10\^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 this trial is running
Hong Kong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.