Actively Recruiting
Immunotherapy and Radioembolisation for Metastatic Hepatocellular Carcinoma
Led by The University of Hong Kong · Updated on 2023-04-12
25
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
T
The University of Hong Kong
Lead Sponsor
Q
Queen Mary Hospital, Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunotherapy and Radioembolisation for Metastatic Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic hepatocellular carcinoma confirmed by imaging with or without biopsy or elevated alpha-feto protein
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Eligible to receive immune checkpoint inhibitors and yttrium-90 microsphere injection
- Baseline CT or MRI imaging with measurable liver lesions within 28 days before treatment
- Able to provide written informed consent
- Adequate blood counts: absolute neutrophil count ≥1.0 x 10^9/l, platelets ≥75 x 10^9/l, hemoglobin ≥9 g/dL
- Adequate liver function: bilirubin ≤1.5 times institutional upper limit of normal (except patients with Gilbert's syndrome after physician consultation), AST/ALT ≤2.5 times upper limit unless liver metastases present (then ≤5 times)
- Creatinine clearance >40 mL/min measured or calculated
You will not qualify if you...
- Participation in another investigational study within 4 weeks or 5 half-lives before treatment
- Severe active autoimmune or rheumatologic disease within 3 months
- Prior monoclonal antibody, immunotherapy, or immune checkpoint inhibitor treatment
- Chemotherapy or targeted therapy within 3 weeks before study drug or unresolved side effects
- Known progressing additional cancers requiring treatment except certain skin cancers, indolent lymphomas, or treated cervical cancer
- Known carcinomatous meningitis
- Active infection needing intravenous treatment or hospitalization
- Conditions or disorders interfering with study participation or safety
- Pregnant, breastfeeding, or planning pregnancy during study and 31 weeks after last dose
- Known HIV infection
- Untreated hepatitis B infection unless on antiviral therapy for at least 1 month and continuing
- Grade 4 toxicity from prior radiation or severe brain toxicity from prior radiation or immunotherapy
- Use of >4mg/day dexamethasone or equivalent steroid at immunotherapy start or recently
- Allergies to study drugs or severe reactions to monoclonal antibodies
- Major surgery within 28 days before first study drug dose (except local palliative surgery)
- QTcF interval ≥470 ms on ECG
- Use of immunosuppressive medication within 14 days before first durvalumab dose except specified steroid uses
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
V
Victor Ho-Fun Lee, MD
CONTACT
M
Mike Law, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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