Actively Recruiting
Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer
Led by Center Eugene Marquis · Updated on 2025-08-06
62
Participants Needed
7
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years old
- ECOG Performance Status less than 2
- Histologically confirmed intrahepatic cholangiocarcinoma
- No prior treatment for intrahepatic cholangiocarcinoma
- Tumor considered resectable by hepatobiliary surgeon and surgical review board
- Significant risk of close surgical margins, defined by any of: predicted margin <1 cm, tumor larger than 5 cm, or multifocal lesion deemed resectable by surgical review board
- Registered with a social security scheme
- Provided informed consent or legal representative consent
You will not qualify if you...
- Severe fibrosis (F3) or cirrhosis (F4)
- Inadequate blood counts or organ functions, including hemoglobin ≤ 8.5 g/dl, neutrophils < 1.5 Giga/L, platelets < 60 Giga/L, bilirubin > 34 µmol/L, ASAT/ALAT > 5 times upper limit, creatinine clearance < 30 ml/min, coagulation abnormalities (TP/INR > 2.3 ULN, TCA > 1.5 ULN)
- Uracil blood level >16 ng/mL
- Respiratory insufficiency
- Severe heart disease or other comorbidities preventing surgery
- Liver conditions such as microvacuolar steatosis > 60% or regenerative nodular hyperplasia for planned major hepatectomy
- Contraindications to hepatic artery catheterization
- Previous chemotherapy or abdominal radiotherapy
- Other invasive cancers
- Participation in another interventional pre-surgery study
- Pregnancy, breastfeeding, or reproductive potential without effective contraception during treatment and 30 days after
- Minors, individuals deprived of liberty, or under guardianship
- Inability to comply with medical follow-up
- Pulmonary shunt dose > 30 Gy
- Non-correctible digestive shunting
- Absence of tumor fixation of MAA (macroaggregated albumin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, France, 35042
Actively Recruiting
2
Groupe SUD-Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux
Pessac, New Aquitaine, France, 33604
Actively Recruiting
3
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
Active, Not Recruiting
4
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86021
Active, Not Recruiting
5
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
6
Hôpital Beaujon
Clichy, Île-de-France Region, France, 92118
Actively Recruiting
7
Hôpital Henri - Mondor
Créteil, Île-de-France Region, France, 94000
Active, Not Recruiting
Research Team
M
Marion Trochet
CONTACT
V
Valérie Jolaine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here