Stereotactic body radiotherapy with atezolizumab and bevacizumab for HCC with major portal vein thrombosis
Stereotactic Body Radiotherapy With Immunotherapy (Atezolizumab Plus Bevacizumab) in Patients With Advanced HCC and Major Portal Vein Tumour Thrombosis
This test tries adding SBRT to atezolizumab plus bevacizumab to see if it helps people with HCC and major portal vein thrombosis who have not progressed after two cycles of systemic therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, prednisone, radiation |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT06823375 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional study tests whether combining stereotactic body radiotherapy (SBRT) with ongoing atezolizumab plus bevacizumab improves outcomes for patients with hepatocellular carcinoma (HCC) and major portal vein tumor thrombosis (PVTT). Eligible adults must have Child‑Pugh A liver function, ECOG 0–1 status, no progression after two cycles of atezolizumab‑bevacizumab, ≤5 intrahepatic lesions, and PVTT amenable to SBRT. Participants receive SBRT targeted to the PVTT in addition to continued systemic atezolizumab and bevacizumab, with scheduled imaging and clinical follow‑up to track response and survival. The trial is conducted at two tertiary oncology centers in Hong Kong.
Who should consider this trial
Good fit: Adults (≥18) with confirmed HCC, major PVTT that can be targeted with SBRT, Child‑Pugh A liver function, ECOG 0–1, no progression after two cycles of atezolizumab plus bevacizumab, and up to five liver lesions (with limited extrahepatic disease allowed) are ideal candidates.
Not a fit: Patients with poorer liver function (Child‑Pugh B/C), uncontrolled or unhealed varices, progression on initial atezolizumab‑bevacizumab, widespread disease not amenable to SBRT, or very limited life expectancy are unlikely to benefit.
Why it matters
Potential benefit: If successful, the combination could improve local control and overall survival for patients with major PVTT who currently have very limited effective options.
How similar studies have performed: Atezolizumab‑bevacizumab has proven survival benefit in HCC and SBRT has shown activity for PVTT in small series, but the specific combination for major PVTT remains relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 18 years old * ECOG performance 0 to 1 * Confirmed diagnosis of HCC (either histologic or cytologic analysis, or clinical features according to the American Association for the Study of Liver Diseases) * Presence of major portal vein thrombosis (Vp3 \[first-order tumour thrombosis in portal vein\] or Vp4 \[tumour thrombosis in the main portal vein, or portal vein branch in contralateral lobe\]), limited to the liver and should be amenable to SBRT * No disease progression after 2 cycles of atezolizumab plus bevacizumab * Presence of ≤5 lesions within the liver * Gastric or esophageal varices must be screened; if interventions were performed, repeated upper endoscopy is needed to confirm healing of treated varices * Child-Pugh A liver function * Life expectancy longer than 3 months * At least one measurable treatment lesion according to RECIST 1.1 * Extrahepatic metastases are allowed, limited to 3 sites, and not causing functional compromise * Written informed consent must be obtained prior to any study related procedures * Adequate haematological function (Hb ≥ 8.5g/dL; Plt ≥ 75x109/L; ANC ≥ 1.5x109/L; INR ≤ 1.5) * Adequate hepatic function (albumin ≥ 28g/L; Bilirubin ≤ 40 μmol/L; ALT \< 5 times upper limit normal) * Adequate renal function (serum creatinine ≤ 2 times the upper limit of normal range; Na ≥ 130mmol/L; K ≥ 3.0mmol/L) * Able to read, understand and provide written consent Exclusion Criteria: * History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years * History of rupture HCC in the past 3 months * History of gastric or esophageal varices with interventions performed within 1 month * Tumour thrombosis that extends beyond the portal vein (e.g. inferior vena cava, superior vena cava) * Liver tumours occupy ≥ 50% of liver * Previous radiotherapy to the abdomen * Previous yttrium-90 chemoembolization * Repetitive history of non-healing wounds or ulcers within 2 months of inclusion * Pregnant or lactating females at any time during the study * Active autoimmune disease requiring systemic therapy in the past 2 years * Diagnosis of immunodeficiency (including HIV) * Ongoing corticosteroid therapy \>10mg prednisone daily
Where this trial is running
Hong Kong and 1 other locations
- Department of Clinical Oncology, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
- Department of Clinical Oncology, Tuen Mun Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Landon CHAN
- 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.