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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT02185768
Eligibility Criteria:
Inclusion Criteria:
* \- Histologically diagnosed HCC or HCC diagnosed according to the EASL criteria
* Measurable targets according to the mRECIST v1.1 criterion
* Preserved liver function (in case of Child-Pugh A or B7 cirrhosis)
* Tumour not subject to interventive care (liver transplant, surgical resection or percutaneous destruction)
* BCLC A/B without portal or extra-hepatic invasion
* No prior treatment by chemotherapy, radiotherapy or transarterial embolisation (with or without chemotherapy)
* Age ≥ 18 years
* WHO 0 or 1
* Laboratory test: platelets ≥ 50,000 mm3, N ≥ 1,000/mm3, creatininaemia ≤ 150 µmol/L, PT ≥ 50%
* No heart failure (isotope or ultrasound VEF \> 50%)
Exclusion Criteria:
* \- Advanced tumour (vascular or extra-hepatic invasion including brain metastasis or diffuse HCC with liver invasion \> 50%)
* History of other type of cancer except cancer known to be in remission for more than 5 years (in this case, HCC histological proof is required), or basal-cell carcinoma or in situ cervix uteri cancer properly treated with curative treatment
* Advanced liver disease (Child B8, B9 and C, bilirubinaemia \> 3 mg/dL, SGOT and SGPT \> 5 x ULN or 250 U/L)
* Previous treatment by idarubicin and/or doxorubicin
* Idarubicin contraindications (cardiopathy with myocardial failure, serious kidney or liver failure, yellow fever vaccine)
* Concurrent disease or uncontrolled severe clinical condition
* Uncontrolled severe infection
* Patient requiring long-term anticoagulant treatment
* Thrombosis of the portal vein or a 3-segment region or more
* Hepatofugal portal venous flow
* Presence of serious atheromatosis
* Presence of collateral vascular ways potentially affecting the normal regions during embolisation
* Presence of arthritis of the hepatic artery branches to be treated
* Presence of arterioportal or arterial subhepatic fistula that cannot be embolised by coils
* Pregnancy or breastfeeding
* Absence of effective contraception (for men and women of childbearing age)
* Patient who cannot be regularly monitored on account of psychological, social, family- or geography-related reasons
* Concomitant participation of a patient in another study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02185768
Study Brief:
Protocol Section:
NCT02185768