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NCT05809869
Immunotherapy and Radioembolisation for Metastatic Hepatocellular Carcinoma
Phase 2 trial testing Durvalumab in Hepatocellular Carcinoma in 25 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | The University of Hong Kong |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 15 February 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 30 June 2026 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Durvalumab — full drug profile →
- Tremelimumab (TREMELIMUMAB) — full drug profile →
- Yttrium-90 radioembolisation
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
The University of Hong Kong
Who can join
18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hepatocellular carcinoma is one of the most intractable primary malignancies in the hepatobiliary and pancreatic tract with a poor overall survival worldwide. Unfortunately, the vast majority of hepatocellular carcinoma patients suffer from advanced unresectable or metastatic disease at diagnosis. Currently targeted therapy alone, or in combination with anti-vascular endothelial growth factor antagonist, is the standard first-line treatment for metastatic hepatocellular carcinoma. On the other hand, there is growing evidence suggesting that radiation therapy (external or internal) with or without immune checkpoint inhibitors can produce or even augment abscopal effect in which the tumours away from the radiation field also show significant tumour shrinkage. The underlying mechanism of eliciting abscopal effect includes the increased antigen presentation by the myeloid cells within the tumour stroma leading to enhanced tumour cell killing. Previous case reports showed that radiation therapy alone can induce abscopal effect in mice and human models. However, a robust and concrete evidence of abscopal effect with combinational immune checkpoint inhibitors and radioembolisation or external radiation therapy in hepatocellular carcinoma is still lacking. This study investigates the efficacy and safety of immune checkpoint inhibitors and radioembolisation as first-line treatment for previously untreated metastatic hepatocellular carcinoma.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Biomarkers for diagnosis and therapeutic options in hepatocellular carcinoma.
Chan YT, Zhang C, Wu J, Lu P, et al · · 2024 · cited 158× · PMID 39242496 · DOI 10.1186/s12943-024-02101-z -
Safety and Efficacy of Concurrent Atezolizumab/Bevacizumab or Nivolumab Combination Therapy with Yttrium-90 Radioembolization of Advanced Unresectable Hepatocellular Carcinoma.
Villalobos A, Dabbous HH, Little O, Gbolahan OB, et al · · 2023 · cited 14× · PMID 38132368 · DOI 10.3390/curroncol30120734 -
Yttrium-90 Radioembolization Dosimetry: Dose Considerations, Optimization, and Tips.
Villalobos A, Pisanie JLD, Gandhi RT, Kokabi N. · · 2024 · cited 6× · PMID 38495257 · DOI 10.1055/s-0044-1779715 -
Immunotherapy and Radiation Therapy Combinatorial Approaches in Hepatocellular Carcinoma.
Tojjari A, Yu J, Saeed A. · · 2024 · cited 5× · PMID 38473415 · DOI 10.3390/cancers16051058 -
Combination of radiotherapy and ICIs in advanced hepatocellular carcinoma: A systematic review of current evidence and future prospects (Review).
Ma C, Yu X, Zhang X, Su L, et al · · 2025 · cited 4× · PMID 40438865 · DOI 10.3892/ol.2025.15088 -
Efficacy and safety of the immune checkpoint inhibitor-radiotherapy combination in advanced/unresectable hepatocellular carcinoma: A systematic review and meta-analysis.
Cui R, Yu X, Jiang Y, Li X. · · 2025 · cited 2× · PMID 40776902 · DOI 10.3892/ol.2025.15206 -
Concurrent Radiation and Immunotherapy for Unresectable Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombus.
Krishnamurthy N, Cherry D, Rodriguez-Russo C, Buckstein M. · · 2025 · PMID 40837214 · DOI 10.1016/j.adro.2025.101856
Verify or expand the search:
- PubMed search for NCT05809869
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
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Other The University of Hong Kong trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05809869 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Hong Kong
- Last refreshed: 12 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05809869.
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