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NCT05797870TerminatedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 2 Jul 2026

Reason given: The last visit of the last patient was done.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
16 (actual)
First submitted
22 Mar 2023
Start date
14 Feb 2024
Primary completion date
13 Jan 2025
Lead sponsor
Center Eugene Marquis
NCT number
NCT05797870
EudraCT number
2020-003250-72

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous SIRT
  • Previous systemic treatment within 4 weeks before radioembolization
  • More than 2 previous TACE (or embolization), in the area to be treated

Other illness

  • Chronic respiratory insufficiency history

Lab values

  • 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
  • Lung shunt >20% evaluated with 99mTc albumin macroaggregate (MAA)
  • Poor tumor targeting with 99mTc albumin macroaggregate (MAA)

Other

  • Known hemophilia with exophytic tumor > 1 cm
  • Extra-hepatic metastasis except hilum node < 2 cm
  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre de Lutte contre le Cancer Eugène MarquisRennesFranceUnknown status

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