CAPECITABINE for Intrahepatic cholangiocarcinoma | Biliary tract cancer

Inclusion criteria

• {"criterion_text":"- 1.\tAge > 18 years-old\n- 2.\tECOG Performance Status <2\n- 3.\tHistologically-proven ICC\n- 4.\tNo previous treatment for ICC\n- 5.\tTumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board\n- 6.\tSignificant risk of close margins, defined as: Resection margin predicted by the surgeon <1cm or Tumour > 5cm or Multifocal lesion deemed resectable, validated by a Surgical Review Board\n- 7.\tRegistration with a social security scheme\n- 8.\tPatient information and signature of informed consent or legal representative"}

Exclusion criteria

• {"criterion_text":"- 1.\tSevere fibrosis (F3) ou cirrhosis (F4)\n- 10.\tOther invasive malignancies\n- 11.\tPatient participate to an interventional study that tests another medical intervention before surgery\n- 12.\tPregnant 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\n- 13.\tMinors, individual deprived of liberty, or under any kind of guardianship\n- 14.\tPatients unable to submit to medical follow-up of the study for social, medical or psychological reasons\n- 2.\tInadequate 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\n- 3.\tUracil blood level >16 ng/mL\n- 4.\tRespiratory insufficiency\n- 5.\tSignificant heart disease or history of heart rhythm disorders, myocardial infarction or angina pectoris in the 6 months prior to inclusion\n- 6.\tPresence of microvacuolar steatosis > 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned\n- 7.\tContraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis)\n- 8.\tPrevious chemotherapy (including for another cancer)\n- 9.\tPrevious abdominal (supra-mesocolic) radiotherapy (including for another cancer)"}

Primary endpoints

• {"endpoint_text":"- Frequency of subjects with adequate surgical margins, defined as the number of resections and margin >= 5mm","definition_or_measurement_approach":"Adequate surgical margins defined as margin >= 5mm; measured as number/proportion of resections meeting this criterion."}
• {"endpoint_text":"- Frequency of subjects actually resected","definition_or_measurement_approach":"Measured as the proportion (frequency) of enrolled subjects who undergo surgical resection."}
• {"endpoint_text":"- Frequency of subjects with R0 and R1 resection","definition_or_measurement_approach":"Measured as proportion of patients with R0 (negative) and R1 (microscopic residual) resection status."}
• {"endpoint_text":"- Frequency of subjects with an observed objective response","definition_or_measurement_approach":"Measured as proportion of patients achieving objective tumour response (per study-specified response criteria)."}
• {"endpoint_text":"- Mean percentage of tissue with necrosis in resected specimen","definition_or_measurement_approach":"Measured as the mean percentage of necrotic tissue observed in the resected surgical specimen."}
• {"endpoint_text":"- Disease-Free survival","definition_or_measurement_approach":"Measured as time from surgery (or randomization per protocol) to recurrence or death (disease-free survival)."}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Measured as time from randomization (or specified baseline) to death from any cause (overall survival)."}

France

Latest Decision Or Authorization Date

13-05-2025

Number Of Sites

8

Number Of Participants

62

Primary sponsor

Full Name

Centre De Lutte Contre Le Cancer Eugene Marquis

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France