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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Capecitabine
DrugCapecitabine 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)
DeviceDuring 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
Procedure/SurgerySurgery will be performed according to local practice.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Capecitabine combined with SIRTExperimental treatment 3 interventions
Group B: Surgery onlyOther 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of subjects with adequate surgical margins
The primary endpoint will be the frequency of subjects with adequate surgical margins, defined as the number of resections AND margin ≥ 5mm.
Time frame
through study completion, an average of 5 yearSponsors and contacts
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Source ClinicalTrials.gov