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

Sponsor
Center Eugene Marquis (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05797870
Collaborator
(none)
35
Enrollment
1
Arm
39
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Jul 15, 2025
Anticipated Study Completion Date :
Dec 15, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Center Eugene Marquis

Investigators

  • Principal Investigator: Etienne Garin, MD PHD, Centre de Lutte contre le Cancer Eugène Marquis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Center Eugene Marquis
ClinicalTrials.gov Identifier:
NCT05797870
Other Study ID Numbers:
  • 2017-1-14-010
  • 2020-003250-72
First Posted:
Apr 4, 2023
Last Update Posted:
Apr 4, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Center Eugene Marquis
Selective Internal Radiation Therapy
188Re-SSS lipiodol
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Ethiodized Oil

Study Results

No Results Posted as of Apr 4, 2023