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

Primary Purpose

Hepatocellular Carcinoma Non-resectable

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Selective Internal Radiation Therapy with 188Re-SSS lipiodol
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Selective Internal Radiation Therapy, 188Re-SSS lipiodol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: 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 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    188Re-SSS lipiodol SIRT

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2023
    Last Updated
    August 22, 2023
    Sponsor
    Center Eugene Marquis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05797870
    Brief Title
    Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)
    Acronym
    Lip-Re2
    Official Title
    Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2024 (Anticipated)
    Primary Completion Date
    December 15, 2025 (Anticipated)
    Study Completion Date
    May 15, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Center Eugene Marquis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma Non-resectable
    Keywords
    Selective Internal Radiation Therapy, 188Re-SSS lipiodol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    188Re-SSS lipiodol SIRT
    Arm Type
    Experimental
    Arm Description
    Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT).
    Intervention Type
    Combination Product
    Intervention Name(s)
    Selective Internal Radiation Therapy with 188Re-SSS lipiodol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The objective response rate
    Description
    Defined as the best overall response occurring within 6 months' post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma
    Time Frame
    through study completion, an average of 4 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marion Trochet
    Phone
    02 99 25 31 65
    Ext
    +33
    Email
    m.trochet@rennes.unicancer.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Valérie Jolaine
    Phone
    02 99 25 30 36
    Ext
    +33
    Email
    v.jolaine@rennes.unicancer.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Etienne Garin, MD PHD
    Organizational Affiliation
    Centre de Lutte contre le Cancer Eugène Marquis
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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