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

NCT05265208 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-08-06

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Center Eugene Marquis

    lead OTHER

Principal Investigators

  • Julien Edeline, MD · Centre de Lutte contre le Cancer Eugène Marquis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2027-09-04
Completion
2030-02-04

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05265208 on ClinicalTrials.gov