Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT03140332
Eligibility Criteria:
Inclusion Criteria:
* Patient aged over 18 years
* Affiliation to a social security scheme
* CHC developed irrespective of the level of fibrosis of the non-tumorous liver, and whatever the etiology
* Advanced hepatocellular carcinoma confirmed histologically or having the typical characteristics in imaging after validation in CPR (abdomino-pelvic CT scan with triphasic injection or hepatic MRI with gadolinium injection): hypervascularized nodule at the early arterial time (wash in) with washing ("Wash out") in relation to the non-tumoral parenchyma
* Hepatocellular carcinoma:
* With a naive measurable target lesion of any treatment
* Who can not benefit from curative treatment (non-operable, non-transplantable, non-radio-frequenable) and who have never benefited from systemic chemotherapy treatment
* Or with appearance after chemo-embolization of target lesions according to the mRECIST criteria in the contralateral liver
* in the case of right or left arteriovenous fistula, the target lesion will be chosen in the contralateral liver
* Indication of treatment by sorafenib after validation in a multidisciplinary consultation meeting:
* Stadium BCLC C
* Cirrhosis classified Child-Pugh A or B7
* Performance status less than or equal to 2
* Preserved haematological function (platelet count ≥ 60000 / mm3, hemoglobin ≥ 8.5 g / dL)
* Hepatic function (albumin ≥ 28 g / L, total bilirubin ≤ 50 μmol / L, ALAT and ASAT ≤ 5 N, INR ≤ 2.3 or TP\> 40%)
* Renal function conserved (creatinine ≤ 1.5 times the upper limit of normal)
Exclusion Criteria:
* Other evolutionary cancer requiring treatment
* History of treatment with sorafenib or anti-angiogenic therapy
* History of treatment by chemoembolization without appearance of target lesion in the contralateral liver
* Diffuse CHC with no measurable lesion
* Patient with TIPS, portal cavernoma, extensive portal thrombosis, or arterio-portal fistula in the same area of assessment of the CHC nodule
* Allergic reaction or hypersensitivity to a contrast agent
* Pregnancy
* Patient under tutorship or curatorship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03140332
Study Brief:
Protocol Section:
NCT03140332