Treatment for non-operable liver cancer using selective internal radiation therapy
Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study
This study is testing a new radiation treatment for people with non-operable liver cancer to see if it can help manage their condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Center Eugene Marquis Academic / other |
| Locations | 1 site (Rennes, Bretagne) |
| Trial ID | NCT05797870 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the efficacy of 188Re-SSS lipiodol in patients with non-resectable hepatocellular carcinoma (HCC). Conducted at a single center, the study will treat 26 patients through a one-day procedure involving the injection of the treatment agent. Patients will be hospitalized for one night for pre-treatment simulation and the actual treatment. Following the procedure, participants will be monitored for disease progression or new therapies for up to 24 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-resectable HCC and a performance status of 0-1.
Not a fit: Patients with severe organ dysfunction or extra-hepatic metastasis may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could improve response rates in patients with non-operable liver cancer.
How similar studies have performed: Other studies have shown promise with selective internal radiation therapy, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rennes, Bretagne
- Centre de Lutte contre le Cancer Eugène Marquis — Rennes, Bretagne, France (Recruiting)
Study contacts
- Principal investigator: Etienne Garin, MD PHD — Centre de Lutte contre le Cancer Eugène Marquis
- Study coordinator: Marion Trochet
- Email: m.trochet@rennes.unicancer.fr
- Phone: 02 99 25 31 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.