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Evaluation of SIRT Followed by Immunotherapy for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis

NCT07122089 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-05

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is the most common primary liver cancer, being the third leading cause of cancer-related death worldwide, with approximately 745 000 deaths reported annually.

For advanced patients, including patients with tumoral portal vein thrombosis (PVT), most treatment guidelines recommend systemic therapy, either combination immunotherapy (IO) or combination of immunotherapy and anti-angiogenic treatment for first line option.

Results for PVT patients are provided in one trial with a median overall survival of 14.2 months with IO underlying the necessity to improve treatment of PVT patients. Two recent other phase 3 trials also reported positive results for different IO regimen.

Selective internal radiation therapy (SIRT) using yttrium-90 (90Y)-loaded glass microspheres (TheraSphereTM) can be used for patients with early stage to locally advanced HCC including PVT patients without extrahepatic spread (EHS). TheraSphereTM is recognized and is reimbursed in France for PVT patients without EHS, since 2019.Several retrospective studies have shown promising results for PVT patients.

Nowadays use of SIRT in locally advanced HCC is regaining interest based on the results of the randomized DOSISPHERE-01 study including non-operable patients, about 70% with PVT. This randomized Phase II trial using 90Y-loaded microspheres sought was noted the effectiveness of 90Y-loaded microspheres using a personalized dosimetry approach versus a standard dosimetry approach.

The use of a systemic treatment as IO after a locoregional treatment with the strong local debulking effect of SIRT is logical and of interest. Indeed, the most frequent pattern of progression after SIRT is recurrence in an untreated area, including untreated liver or EHS. Patients are then usually referred to IO.

Such kind of therapeutic approach, using SIRT followed by IO has already been evaluated in a phase 2 study using nivolumab after 90Y loaded resin microspheres with promising efficacy without safety deterioration.

The aim of this study is to evaluate SIRT followed by IO used according to their current indications in advanced HCC patient with PVT patients and without EHS.

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

DEVICE

Selective Internal Radiotherapy

SIRT will use Yttrium-90 glass-microspheres (TheraSphereTM). SIRT needs two steps: the treatment simulation (diagnostic angiography and scintigraphy of hepatic perfusion with 99mTc-MAA) and the administration (during a therapeutic angiography).

DRUG

Tremelimumab

Tremelimumab should be done 1 to 3 weeks after SIRT and is administrated according to the Summary of Product Characteristic (SPC).

DRUG

Durvalumab

After the end of the tremelimumab infusion, patient receive durvalumab then one injection every 4 weeks until further progression upon investigator decision. Also administrated according to the Summary of Product Characteristic (SPC).

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Center Eugene Marquis

    lead OTHER

Principal Investigators

  • Etienne Garin, MD PHD · Centre de Lutte Contre Le cancer Eugène Marquis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2030-01-02
Completion
2030-01-02

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07122089 on ClinicalTrials.gov