Selective Internal Radiation Therapy and Capecitabine (chemotherapy) treatment for liver cancer

Phase 1

• Conditions: Patients having operable intrahepatic cholangiocarcinoma; MedDRA version: 20.0Level: LLTClassification code 10073077Term: Intrahepatic cholangiocarcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001575-16-FR
• Lead Sponsor: Centre Régional de lutte contre le Cancer Eugène Marquis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-02
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Age > 18 years-old,
ECOG Performance Status <2
Histologically-proven ICC
No previous treatment,
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 <1cm
-Tumour > 5cm
-Multifocal lesion deemed resectable, validated by a Surgical Review Board
Patient information and signature of informed consent or legal representative.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

Cirrhosis,
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
Other invasive malignancies in the past 3 years,
Patient participate to an interventional study that tests another medical intervention before surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified