Clinical trial NCT05797870: Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma Non-resectable
Keywords: Selective Internal Radiation Therapy
188Re-SSS lipiodol
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  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
* 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.

Primary outcomes:
measure: The objective response rate
timeFrame: through study completion, an average of 4 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre de Lutte contre le Cancer Eugène Marquis
state: Bretagne
Study officials:
affiliation: Centre de Lutte contre le Cancer Eugène Marquis
name: Etienne Garin, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: