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

Center Eugene Marquis

Status and phase: Suspended; Phase 2

Conditions: Hepatocellular Carcinoma Non-resectable

Treatments: Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol

Study type: Interventional

Funder types: Other

Identifiers

NCT05797870

2020-003250-72 (EudraCT Number)

2017-1-14-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

188Re-SSS lipiodol SIRT

Experimental group

Description:

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

Treatment:

Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol