Status:
RECRUITING
Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer
Lead Sponsor:
Center Eugene Marquis
Conditions:
Resectable Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 capecitab...
Detailed Description
The study plans to randomized eligible and consent patients in two balanced parallel groups, the one defined as the experimental arm while the second consisting in the actual standard of care is defin...
Eligibility Criteria
Inclusion
- Age \> 18 years-old,
- ECOG Performance Status \<2,
- Histologically-proven ICC,
- No previous treatment for ICC,
- Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board,
- Significant risk of close margins, defined as:
- Resection margin predicted by the surgeon \<1 cm
- Tumour \>5 cm
- Multifocal lesion deemed resectable, validated by a Surgical Review Board
- Registration with a social security scheme,
- Patient information and signature of informed consent or legal representative.
- Non-inclusion Criteria:
- Severe fibrosis (F3) ou cirrhosis (F4),
- Inadequate haematological, hepatic, renal and coagulation functions:
- Haemoglobin ≤ 8,5 g/dl
- Neutrophils \< 1,5 Giga/L
- Platelets \< 60 Giga/L
- Bilirubin \> 34 µmol/L
- ASAT/ALAT \> 5 x ULN
- Creatinine clearance \< 30 ml/min (MDRD)
- TP et INR \> 2,3 ULN
- TCA \> 1,5 x ULN
- Uracil blood level \>16 ng/mL,
- Respiratory insufficiency,
- Comorbidity precluding surgical resection, such as severe heart disease,
- Presence of microvacuolar steatosis \> 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned,
- Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis),
- Previous chemotherapy (including for another cancer),
- Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer),
- Other invasive malignancies,
- Patient participate to an interventional study that tests another medical intervention before surgery,
- 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,
- Minors, individual deprived of liberty, or under any kind of guardianship,
- Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.
Exclusion
- Pulmonary shunt with dose \>30Gy,
- Digestive shunting, non-correctible by interventional radiology,
- Absence of fixation of MAA in the tumour.
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 4 2030
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05265208
Start Date
February 4 2022
End Date
February 4 2030
Last Update
August 6 2025
Active Locations (7)
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1
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, France, 35042
2
Groupe SUD-Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux
Pessac, Nouvelle-Aquitaine, France, 33604
3
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
4
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86021