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Terminated
NCT05797870
Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)
Conditions: Hepatocellular Carcinoma Non-resectable
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 16
Sponsor: Center Eugene Marquis
Location: Centre de Lutte contre le Cancer Eugène Marquis Rennes Brittany Region
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.
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 \ 6 UNL
6. Creatinine \> 1,5 UNL
7. 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
* 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.
Source: ClinicalTrials.gov (NCT05797870). StuddyBuddy aggregates publicly available trial information.