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Clinical Trials in France / NCT05265208
Recruiting Phase 2

Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer

NCT05265208 · tracked via the Priya Life Science France tracker
Sponsor
Center Eugene Marquis
Phase
Phase 2
Started
2022-02-04
Last updated
2025-08-06

Condition(s) studied

Resectable Intrahepatic Cholangiocarcinoma

Investigational drug(s) / intervention(s)

Capecitabine →Selective Internal Radiotherapy (SIRT)Surgery

Capecitabine: Capecitabine will given at 1250mg/m², 2 times a day with an interval of about 12 hours between two intakes, 2 weeks on, 1 week off, for 4 pre-surgery cycles.

Selective Internal Radiotherapy (SIRT): During the first week of cycle 2 of capecitabine, patients will receive SIRT using Yttrium-90 glass microspheres. Treatment with Yttrium-90 glass microspheres requires two steps, one or two weeks apart. Both stages are performed under local anesthesia after a short hospitalization : the treatment simulation and therapeutic angiography.

Surgery: Surgery will be performed according to local practice.

Study summary

Treatment of intrahepatic cholangiocarcinoma (ICC) remains difficult. Many patients have unresectable tumors, and survival after resection was only slightly improved with the use of adjuvant capecitabine. One of the major prognostic factors is the resection margin, patients with invaded (R1) or narrow (\<5mm) margins having a higher risk of recurrence.

Selective Internal Radiation Therapy (SIRT) with Yttrium-90 microspheres (also known as SIRT) is an interesting treatment in unresectable ICC. In a phase 2 study, the investigators showed a response rate of 39% and a disease control rate of 98%. Interestingly, 9 of the 41 patients were able to see their tumors downstages to surgery. It was also recently suggested in a retrospective study that patients resected after SIRT had a better prognosis than patients that could be operated upfront, despite less favorable initial tumor characteristics.

Given the absence of validated neoadjuvant treatment, the promising activity of SIRT and chemotherapy combination in the unresectable setting, and the prognostic significance of close surgical margins, the aim of this trial is therefore to study this combination treatment in the neoadjuvant setting of resectable ICC.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age \> 18 years-old, 2. ECOG Performance Status \<2, 3. Histologically-proven ICC, 4. No previous treatment for ICC, 5. Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board, 6. Significant risk of close margins, defined as: 1. Resection margin predicted by the surgeon \<1 cm 2. Tumour \>5 cm 3. Multifocal lesion deemed resectable, validated by a Surgical Review Board 7. Registration with a social security scheme, 8. Patient information and signature of informed consent or legal representative. Non-inclusion Criteria: 1. Severe fibrosis (F3) ou cirrhosis (F4), 2. Inadequate haematological, hepatic, renal and coagulation functions: 1. Haemoglobin ≤ 8,5 g/dl 2. Neutrophils \< 1,5 Giga/L 3. Platelets \< 60 Giga/L 4. Bilirubin \> 34 µmol/L 5. ASAT/ALAT \> 5 x ULN 6. Creatinine clearance \< 30 ml/min (MDRD) 7. TP et INR \> 2,3 ULN 8. TCA \> 1,5 x ULN 3. Uracil blood level \>16 ng/mL, 4. Respiratory insufficiency, 5. Comorbidity precluding surgical resection, such as severe heart disease, 6. Presence of microvacuolar steatosis \> 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned, 7. Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis), 8. Previous chemotherapy (including for another cancer), 9. Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer), 10. Other invasive malignancies, 11. Patient participate to an interventional study that tests another medical intervention before surgery, 12. Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 30 days after the end of the treatment adjuvant, 13. Minors, individual deprived of liberty, or under any kind of guardianship, 14. Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons. Exclusion Criteria: 1. Pulmonary shunt with dose \>30Gy, 2. Digestive shunting, non-correctible by interventional radiology, 3. Absence of fixation of MAA in the tumour.

Primary outcome measure(s)

  • Frequency of subjects with adequate surgical margins — through study completion, an average of 5 year
    The primary endpoint will be the frequency of subjects with adequate surgical margins, defined as the number of resections AND margin ≥ 5mm.

Trial sites (7)

FacilityCityRegionStatus
Centre de Lutte contre le Cancer Eugène Marquis Rennes Brittany Region Recruiting
Groupe SUD-Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux Pessac New Aquitaine Recruiting
Centre Hospitalier Universitaire de Montpellier Montpellier France Active Not Recruiting
Centre Hospitalier Universitaire de Poitiers Poitiers France Active Not Recruiting
Gustave Roussy Villejuif France Recruiting
Hôpital Beaujon Clichy Île-de-France Region Recruiting
Hôpital Henri - Mondor Créteil Île-de-France Region Active Not Recruiting

More Center Eugene Marquis trials in France

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Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer Recruiting
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Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy Recruiting
Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05265208 on ClinicalTrials.gov ↗ ← All trials in France