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

NCT04124991 | Completed Phase 1

• 1 other identifier: SOLID
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and Efficacy Study of Radioembolization with Yttrium-90 Microspheres in Combination with Durvalumab in Locally Advanced Hepatocellular Carcinoma

Conditions

Hepatocellular Carcinoma

Keywords

HCC; Durvalumab

Outcome Measures

Primary Outcomes (1)

• TTP

  to evaluate time to progression (TTP) from enrolment using Modified Response Evaluation Criteria in Solid Tumors (mRECIST).

  From date of enrollment until the date of first documented progression, assessed up to 12 months

Secondary Outcomes (3)

• OS

  From date of enrollment until the date of first documented progression, assessed up to 12 months

• ORR

  From date of enrollment until the date of first documented progression, assessed every 8 weeks up to 12 months.

• Number of participants with treatment-related adverse events

  Until 30 days after radioembolization with yttrium-90 microspheres or the last dose of durvalumab

Study Arms (1)

Yttrium-90 Microspheres in Combination with Durvalumab

EXPERIMENTAL

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.

Drug: Durvalumab; Radiation: Radioembolization

Interventions

Durvalumab DRUG

Radioembolization with Yttrium-90 Microspheres

Also known as: Imfinzi®

Yttrium-90 Microspheres in Combination with Durvalumab

Radioembolization RADIATION

Radioembolization with Yttrium-90 Microspheres

Also known as: TheraSphere™

Yttrium-90 Microspheres in Combination with Durvalumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yoon Jun Kim, MD. PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: October 14, 2019
• Study Start: June 12, 2020
• Primary Completion: July 6, 2022
• Study Completion: July 28, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)