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RECRUITING

NCT05265208

PHASE2

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

Sponsor: Center Eugene Marquis

View on ClinicalTrials.gov

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.

Official title: A Multicenter Open-label Randomized Controlled Prospective Phase II Study Evaluating the Efficacy of Selective Internal Radiation Therapy (Yttrium-90 Glass Microspheres) Combined With Capecitabine in the Neoadjuvant Setting of Operable Intrahepatic CHOlangiocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-02-04

Completion Date

2030-02-04

Last Updated

2025-08-06

Healthy Volunteers

Conditions

Resectable Intrahepatic Cholangiocarcinoma

Interventions

DRUG

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.

DEVICE

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.

PROCEDURE

Surgery

Surgery will be performed according to local practice.

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.

Locations (7)

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, France

Groupe SUD-Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux

Pessac, Nouvelle-Aquitaine, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Gustave Roussy

Villejuif, France

Hôpital Beaujon

Clichy, Île-de-France Region, France

Hôpital Henri - Mondor

Créteil, Île-de-France Region, France