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

Hepatocellular Carcinoma Non-resectable Clinical Trial

— Lip-Re2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797870
• Other study ID #: 2017-1-14-010
• Secondary ID: 2020-003250-72
• Status: Recruiting
• Phase: Phase 2
• Start date: February 14, 2024
• Est. completion date: May 14, 2027

Study information

• Verified date: April 2024
• Source: Center Eugene Marquis
• Contact: Marion Trochet
• Phone: 02 99 25 31 65
• Email: m.trochet[@]rennes.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: May 14, 2027
• Est. primary completion date: December 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Intervention

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.

Locations

Country	Name	City	State
France	Centre de Lutte contre le Cancer Eugène Marquis	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective response rate	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