Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2) (Lip-Re2)

March 17, 2026 updated by: Center Eugene Marquis

Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study

The goal of this monocentric interventional study is to evaluate the efficacy, in terms of objective response rate, of the 188Re-SSS lipiodol SIRT in patients with non-operable HCC.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

This study is an open-labelled treatment administration study conducted with an exact one-stage one-arm study plan.

The study plans to included 35 patients and to treated 26 patients (take into account screen failures and SIRT contraindications).

The treatment is delivered by a one-day procedure leading to the injection of 188Re-SSS lipiodol. In details, the patient is hospitalized for one night. Two steps are performed while the patient is hospitalized: the pre-treatment simulation step and the treatment step itself.

After treatment, patients are followed until progression, new systemic or locoregional (in the same treatment area) antineoplastic therapy or death, within a maximum 24-month period following the SIRT.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Brittany Region
      • Rennes, Brittany Region, France, 35042
        • Centre de lutte contre le cancer Eugène Marquis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18
  • ECOG Performance Status 0-1
  • HCC with histological diagnosis or non-invasive diagnosis according to AASLD criteria
  • Non operable and not accessible to ablation therapy
  • At least one measurable lesion using mRECIST
  • Tumor involvement <50% of the liver
  • BCLC classification A to C
  • Compensated cirrhosis (Child Pugh A or B7), if cirrhosis present
  • Registration with a social security scheme
  • Written and informed consent of the patient or his/her legal representative

Exclusion Criteria:

  • Inadequate hematological, hepatic, renal, thyroid and coagulation functions:

    1. Hemoglobin < 8,5 g/dl
    2. Granulocytes < 1500/mm3
    3. Platelets< 50 000 /mm3
    4. Bilirubin level ≥ 35 mol/l
    5. Transaminases > 6 UNL
    6. Creatinine > 1,5 UNL
    7. TSH < 0,2 µUI/L
  • Chronic respiratory insufficiency history
  • Known hemophilia with exophytic tumor > 1 cm
  • Extra-hepatic metastasis except hilum node < 2 cm
  • Lung shunt >20% evaluated with 99mTc albumin macroaggregate (MAA)
  • Poor tumor targeting with 99mTc albumin macroaggregate (MAA)
  • Previous SIRT
  • Previous systemic treatment within 4 weeks before radioembolization
  • More than 2 previous TACE (or embolization), in the area to be treated
  • Other neoplasia except if complete remission from at least one year
  • Contraindication related to the technique, in particular severe arterial pathology of the lower limbs or the aorta contraindicating or making difficult an arteriography by femoral approach
  • Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 1 month after the end of the treatment
  • Minors, individual deprived of liberty, or under any kind of guardianship or trusteeship.
  • Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 188Re-SSS lipiodol SIRT
Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT).
Combination product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol

The treatment with 188Re-SSS lipiodol SIRT requires two steps during the patient's hospitalization: the pre-treatment simulation step and the treatment step itself.

Pre-therapeutic simulation is performed during the screening phase, before definite patient inclusion, and is composed of two procedures: a diagnostic liver angiography and a liver perfusion scintigraphy (MAA scan and SPECT/CT).

The therapeutic stage is also composed of two procedures a therapeutic liver angiography with 188Re-SSS lipiodol and a 188Re-SSS lipiodol SPECT/CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The objective response rate
Time Frame: through study completion, an average of 4 year
Defined as the best overall response occurring within 6 months' post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma
through study completion, an average of 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Etienne Garin, MD PHD, Centre de lutte contre le cancer Eugène Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

April 14, 2026

Study Completion (Estimated)

April 14, 2026

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1-14-010
  • 2020-003250-72 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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