Yttrium‑90 internal radiation plus capecitabine before liver surgery for intrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase 2 trial comparing neoadjuvant selective internal radiation therapy (SIRT) with Yttrium‑90 plus 12 weeks of capecitabine versus immediate (upfront) surgery for patients with resectable intrahepatic cholangiocarcinoma at high risk of narrow margins. Patients in the experimental arm receive SIRT and oral capecitabine, undergo imaging at about 10 weeks, and—if still resectable—proceed to surgery around week 16; patients in the control arm go directly to surgery. After surgery all patients enter the same follow‑up schedule with clinical reviews every 3 months for 2 years and then every 6 months for 3 more years, with CT imaging at the scheduled visits. Key eligibility includes age >18, ECOG <2, histologically proven ICC judged resectable but with predicted close margins, and adequate organ function, while advanced fibrosis/cirrhosis or major lab abnormalities exclude participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 18 years-old,
2. ECOG Performance Status \<2,
3. Histologically-proven ICC,
4. No previous treatment for ICC,
5. Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board,
6. Significant risk of close margins, defined as:

   1. Resection margin predicted by the surgeon \<1 cm
   2. Tumour \>5 cm
   3. Multifocal lesion deemed resectable, validated by a Surgical Review Board
7. Registration with a social security scheme,
8. Patient information and signature of informed consent or legal representative.

Non-inclusion Criteria:

1. Severe fibrosis (F3) ou cirrhosis (F4),
2. Inadequate haematological, hepatic, renal and coagulation functions:

   1. Haemoglobin ≤ 8,5 g/dl
   2. Neutrophils \< 1,5 Giga/L
   3. Platelets \< 60 Giga/L
   4. Bilirubin \> 34 µmol/L
   5. ASAT/ALAT \> 5 x ULN
   6. Creatinine clearance \< 30 ml/min (MDRD)
   7. TP et INR \> 2,3 ULN
   8. TCA \> 1,5 x ULN
3. Uracil blood level \>16 ng/mL,
4. Respiratory insufficiency,
5. Comorbidity precluding surgical resection, such as severe heart disease,
6. Presence of microvacuolar steatosis \> 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned,
7. Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis),
8. Previous chemotherapy (including for another cancer),
9. Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer),
10. Other invasive malignancies,
11. Patient participate to an interventional study that tests another medical intervention before surgery,
12. Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 30 days after the end of the treatment adjuvant,
13. Minors, individual deprived of liberty, or under any kind of guardianship,
14. Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.

Exclusion Criteria:

1. Pulmonary shunt with dose \>30Gy,
2. Digestive shunting, non-correctible by interventional radiology,
3. Absence of fixation of MAA in the tumour.

Where it's running

• 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 Recruiting
• Centre Hospitalier Universitaire de Poitiers
  Poitiers, France Recruiting
• Gustave Roussy
  Villejuif, France Recruiting
• Hôpital Beaujon
  Clichy, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: Julien Edeline, MD — Centre de Lutte contre le Cancer Eugène Marquis
• Study coordinator: Marion Trochet
• Email: m.trochet@rennes.unicancer.fr
• Phone: 02 99 25 31 65

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.