RecruitingPhase 2NCT05265208

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

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


Sponsor

Center Eugene Marquis

Enrollment

62 participants

Start Date

Feb 4, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving internal radiation therapy (Y-90 SIRT) plus oral chemotherapy (capecitabine) before surgery can improve outcomes for people with bile duct cancer inside the liver (intrahepatic cholangiocarcinoma). The treatment is given to people whose cancer is resectable but where the surgical margin is expected to be very close or tight. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with bile duct cancer inside the liver (intrahepatic cholangiocarcinoma), confirmed by biopsy - You have not received any prior treatment for this cancer - Your cancer is considered surgically removable, but with a close predicted margin or large tumor size - You are in generally good physical condition (ECOG 0–1) **You may NOT be eligible if...** - You have severe liver scarring (advanced fibrosis or cirrhosis) - Your blood counts, liver, or kidney function is below acceptable levels - You are pregnant or breastfeeding - You have had prior surgery for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

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.

DEVICESelective 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.

PROCEDURESurgery

Surgery will be performed according to local practice.


Locations(7)

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, France

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

Pessac, New 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

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NCT05265208


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