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

Hepatocellular Carcinoma Clinical Trial

— SOLID  

Official title:

A Single-arm, Open-label, Safety and Efficacy Study of Radioembolization With Yttrium-90 Microspheres in Combination With Durvalumab (MEDI4736) in Locally Advanced and Unresectable Hepatocellular Carcinoma (HCC) (SOLID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124991
• Other study ID #: SOLID
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 12, 2020
• Est. completion date: July 28, 2022

Study information

• Verified date: March 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 28, 2022
• Est. primary completion date: July 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Exclusion Criteria Specific to Radioembolization:

•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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Durvalumab
Radioembolization with Yttrium-90 Microspheres

Radiation:
• Radioembolization
Radioembolization with Yttrium-90 Microspheres

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OS	Overall Survival (OS) from first dose of study drug until the time of data cut-off, as determined by the Investigator.	From date of enrollment until the date of first documented progression, assessed up to 12 months
Secondary	ORR	Objective Response Rate (ORR) of Target Lesion(s) and Non-Target Lesion(s)	From date of enrollment until the date of first documented progression, assessed every 8 weeks up to 12 months.
Secondary	Number of participants with treatment-related adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Until 30 days after radioembolization with yttrium-90 microspheres or the last dose of durvalumab