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

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma Non-resectable
• Interventions: Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol

• Registration Number: NCT05797870
• Lead Sponsor: Center Eugene Marquis

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-04
• Study Start: 2024-02-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-12-14
• Study Completion: 2027-05-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
188Re-SSS lipiodol SIRT	Selective Internal Radiation Therapy with 188Re-SSS lipiodol	Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT).

Primary Outcome Measures

Name	Time	Method
The objective response rate	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

Trial Locations

Locations (1)

Centre de Lutte contre le Cancer Eugène Marquis; 🇫🇷 Rennes, Bretagne, France