Hepatocellular Carcinoma
Conditions
Keywords
HCC, Durvalumab
Brief summary
Safety and Efficacy Study of Radioembolization with Yttrium-90 Microspheres in Combination with Durvalumab in Locally Advanced Hepatocellular Carcinoma
Detailed description
This is a single arm, open-label study to evaluate safety and efficacy of Radioembolization with Yttrium-90 Microspheres in Combination with Durvalumab in Locally Advanced and Unresectable Hepatocellular Carcinoma which to be implemented at a single site in Korea. Transarterial radioembolization (TARE) with yttrium-90 microspheres will be employed in combination with an intravenous (IV) durvalumab until PD. TARE will be performed before the first dose of durvalumab. Exploratory biomarker testing will be done on tumor tissues prior to treatment and plasma samples prior to treatment and at the time of PD.
Interventions
DRUGDurvalumab
Radioembolization with Yttrium-90 Microspheres
RADIATIONRadioembolization
Radioembolization with Yttrium-90 Microspheres
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Transarterial radioembolization (TARE) with yttrium-90 microspheres will be employed in combination with an intravenous (IV) dose of 1500 mg durvalumab every 4 weeks (Q4W) until PD. TARE will be performed 1-2 weeks (7 to 14 days) before the first dose of durvalumab and a maximum of 2 more times during the treatment period, per Investigator discretion. If additional TARE is performed, the interval between additional TARE treatments and administration of durvalumab should be at least 1 week.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with unequivocal HCC confirmed histologically or diagnosed radiologically * Locally advanced HCC * Must have at least 1 untreated measurable disease * Child-Pugh score ≤7 points * Adequate normal organ and marrow function.
Exclusion criteria
* Eligible for potentially curative treatment (surgical resection, radio-frequency ablation or immediate liver transplantation) * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody * Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid cancer, early gastric cancer, or other cancer for which the patient has been disease-free for at least five years. * Evidence of extrahepatic metastasi(e)s, except for regional lymph node(s) involvement * History of leptomeningeal carcinomatosis , History of active primary immunodeficiency * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TTP | From date of enrollment until the date of first documented progression, assessed up to 12 months | to evaluate time to progression (TTP) from enrolment using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From date of enrollment until the date of first documented progression, assessed up to 12 months | Overall Survival (OS) from first dose of study drug until the time of data cut-off, as determined by the Investigator. |
| ORR | From date of enrollment until the date of first documented progression, assessed every 8 weeks up to 12 months. | Objective Response Rate (ORR) of Target Lesion(s) and Non-Target Lesion(s) |
| Number of participants with treatment-related adverse events | Until 30 days after radioembolization with yttrium-90 microspheres or the last dose of durvalumab | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Countries
South Korea
Outcome results
None listed