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

Launched by CENTER EUGENE MARQUIS · Mar 22, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer" is investigating a new treatment for patients with a type of liver cancer called hepatocellular carcinoma (HCC) that cannot be surgically removed. The main goal of the study is to see how effective a specific therapy, known as 188Re-SSS lipiodol SIRT, is in shrinking tumors in patients who have measurable lesions and certain other health criteria. This trial is currently recruiting participants, and anyone aged 18 or older, who has a confirmed diagnosis of HCC and meets specific health conditions, may be eligible to join.

Participants in the trial can expect to receive this treatment and be closely monitored for their response to it. To take part, individuals should not have severe liver issues and should not have received certain other treatments recently. It’s important that participants understand the commitment involved, including medical follow-ups and providing informed consent. This study aims to provide a new option for patients with liver cancer who have limited treatment choices, and it may help improve future care for others facing similar challenges.

Gender

ALL

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.