Stereotactic body radiotherapy with atezolizumab and bevacizumab for HCC with major portal vein thrombosis
Official title: Stereotactic Body Radiotherapy With Immunotherapy (Atezolizumab Plus Bevacizumab) in Patients With Advanced HCC and Major Portal Vein Tumour Thrombosis
Run by Chinese University of Hong Kong · NCT06823375 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | prednisone, atezolizumab, bevacizumab, radiation |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Status | Recruiting |
| Started | July 10, 2025 |
| Main results expected | March 31, 2029 |
| Study ends | March 31, 2030 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT06823375 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 * 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 ≥ 75x10\^9/L; ANC ≥ 1.5x10\^9/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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Blood biomarkers to predict response to atezolizumab plus bevacizumab in hepatocellular carcinoma
This study tests whether blood-based biomarkers can predict which patients with advanced liver cancer will respond to first-line atezolizumab plus bevacizumab.
-
AI system to predict response to Atezolizumab-Bevacizumab in unresectable liver cancer
This study looks at whether an artificial intelligence tool can predict how patients with unresectable hepatocellular carcinoma will respond to atezolizumab-bevacizumab.
-
TIPS benefits for people with hepatocellular carcinoma taking Tecentriq (atezolizumab) plus Avastin (bevacizumab) as first-line therapy.
This study will try to see if placing a TIPS device helps people with advanced or unresectable hepatocellular carcinoma who are starting first-line treatment with Tecentriq plus Avastin.
-
Bevacizumab followed by atezolizumab versus both together for advanced hepatocellular carcinoma with MASLD
This test will see if giving bevacizumab first and then atezolizumab works better than giving both at the same time for adults with advanced hepatocellular carcinoma and metabolic-associated steatotic liver disease (MASLD).
-
Using fecal microbiota transplantation to try to restore response to atezolizumab and bevacizumab in people with unresectable hepatocellular carcinoma.
This will try whether giving a fecal microbiota transplant and then restarting atezolizumab plus bevacizumab can restore treatment response in adults with unresectable HCC who progressed early on those drugs.
-
Trimipramine with atezolizumab and bevacizumab for recurrent glioblastoma
Researchers will try whether adding the antidepressant trimipramine to the immunotherapy atezolizumab plus bevacizumab helps people with recurrent glioblastoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.