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

NCT05797870 | Suspended Phase 2 DMC

• 2 other identifiers: 2017-1-14-0102020-003250-72
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Selective Internal Radiation Therapy; 188Re-SSS lipiodol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

188Re-SSS lipiodol SIRT

EXPERIMENTAL

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

Interventions

Selective Internal Radiation Therapy with 188Re-SSS lipiodol COMBINATION_PRODUCT

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.

188Re-SSS lipiodol SIRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate hematological, hepatic, renal, thyroid and coagulation functions:
• Hemoglobin \< 8,5 g/dl
• Granulocytes \< 1500/mm3
• Platelets\< 50 000 /mm3
• Bilirubin level ≥ 35 mol/l
• Transaminases \> 6 UNL
• Creatinine \> 1,5 UNL
• 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

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (1)

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, 35042, France

Location

MeSH Terms

Interventions

rhenium-SSS-lipiodol

Study Officials

• Etienne Garin, MD PHD

  Centre de Lutte contre le Cancer Eugène Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: February 14, 2024
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)