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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter Eugene Marquis

About this trial

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 criteria

Qualifiers

Age > 18 years-old,

ECOG Performance Status <2,

Histologically-proven ICC,

No previous treatment for ICC,

Disqualifiers

Pulmonary shunt with dose >30Gy,

Digestive shunting, non-correctible by interventional radiology,

Absence of fixation of MAA in the tumour.

Trial design

Treatments tested in this trial

  • Capecitabine
  • Selective Internal Radiotherapy (SIRT)
  • Surgery

Treatment groups

62 Participants
are divided into 2 treatment groups

Sponsors and collaborators