Safety and Efficacy Study of Radioembolization in Combination With Durvalumab in Locally Advanced and Unresectable HCC

NCT ID: NCT04124991

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2022-07-28

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yttrium-90 Microspheres in Combination with Durvalumab

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.

Group Type: EXPERIMENTAL

Durvalumab

Intervention Type: DRUG

Radioembolization with Yttrium-90 Microspheres

Radioembolization

Intervention Type: RADIATION

Radioembolization with Yttrium-90 Microspheres

Interventions

Durvalumab

Radioembolization with Yttrium-90 Microspheres

Intervention Type: DRUG

Radioembolization

Radioembolization with Yttrium-90 Microspheres

Intervention Type: RADIATION

Other Intervention Names

Imfinzi®; TheraSphere™

Eligibility Criteria

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.

•The screening angiogram and technetium-99m macroaggregated albumin (99mTc-MAA) scan are used to determine lobar liver volume from CT or MR images, to identify vascular shunting to the GI tract requiring use of angiographic occlusion techniques and to determine the lung shunt fraction.

Patients who are ineligible to radioembolization meeting the following criteria will not be included in the study. Additional patients will be screened to replace those patients.

• Deposition of yttrium-90 microspheres to the GI tract that cannot be corrected by placement of the catheter distal to collateral vessels or the application of standard angiographic techniques, such as coil embolization to prevent deposition of yttrium-90 microspheres in the GI tract.
• Exposure of radiation to the lungs exceeds 30 Gray (Gy) for a single infusion or 50 Gy cumulative for all infusions of yttrium-90 microspheres.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yoon Jun Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoon Jun Kim, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SOLID

Identifier Type: -

Identifier Source: org_study_id