Condition: Resectable Intrahepatic Cholangiocarcinoma · Sponsor: Center Eugene Marquis
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.
This description comes directly from the study's public registry record.
Marion Trochet · 02 99 25 31 65 · m.trochet@rennes.unicancer.fr
Valérie Jolaine · 02 99 25 30 36 · v.jolaine@rennes.unicancer.fr
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| Centre de Lutte contre le Cancer Eugène Marquis | Rennes, Brittany Region, France | Recruiting |
| Groupe SUD-Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux | Pessac, New Aquitaine, France | 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, France | Recruiting |
| Hôpital Henri - Mondor | Créteil, Île-de-France Region, France | Active Not Recruiting |
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Source record: clinicaltrials.gov/study/NCT05265208