Immunotherapy and Radioembolisation for Metastatic Hepatocellular Carcinoma

Sponsor
The University of Hong Kong
Study ID
NCT05809869
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500mg intravenous infusion on week 1, 5, 9, 13, 17, 21 and 25 for a total of 7 cycles
  • Tremelimumab — DRUG
    Tremelimumab 300mg intravenous infusion on week 1 only.
  • Yttrium-90 radioembolisation — RADIATION
    Yttrium-90 radioembolisation on week 2 only.

Study Details

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.

Key Dates

Start date
Feb 15, 2023
Status verified
Feb 2023
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab in combination with tremelimumab and radioembolisation
    1. Tremelimumab 300 mg intravenous infusion on week 1 only 2. Durvalumab 1500mg intravenous infusion on week 1, 5, 9, 13, 17, 21 and 25, for a total of 7 cycles 3. Radioembolisation with yttrium-90 microspheres on week 2 only

Primary Outcome Measure

Best objective response [ Time Frame: 3 years ]

Central Contacts

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