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:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT02582034
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18,
* Written free and informed consent,
* Histologically demonstrated Hepatocellular Carcinoma (HCC), not a candidate for surgery or local ablative treatment (radio frequency, etc.)
* Barcelona Clinic Liver Cancer (BCLC) classification A, B or C,
* At least one lesion ≥ 7 cm,
* Hepatic reserve (hepatic parenchyma not treated) after the first SIRT ≥ 30%,
* Unilateral involvement, minimal bilateral involvement allowed only with a hepatic reserve ≥ 30% after SIRT
* Child A classification only, or B but with bilirubinemia \<35 micromol/L,
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1,
* Patients whose biological parameters meet the following criteria:
* Hemoglobin ≥ 8.5 g/dL,
* Granulocytes ≥ 1500/mm3,
* Platelets ≥ 50,000/mm3,
* Bilirubinemia \<35 micromol per liter,
* Transaminases ≤ five times the upper limit of normal,
* Creatininemia ≤ 1.5 times the normal upper limit,
* Expected survival over 12 weeks,
* Negative pregnancy test for women of childbearing age,
* If sorafenib has been taken the diagnostic angiogram must follow it by at least four weeks after its stop.
Exclusion Criteria:
* HCC operable or accessible to a local ablative treatment (radio frequency),
* Hepatectomy history unless a segmental treatment is considered, with a hepatic reserve ≥ 30% after SIRT,
* Prior treatment with sorafenib unless stopped at least four weeks earlier,
* History of chemo-embolization of the principal lesion, except in case of nodular residual lesion measuring at least 7 cm or in case of progression after initial response,
* Bilateral disease requiring a whole liver injection or with a hepatic reserve \< 30% after SIRT
* Treatment of another cancer less than one year earlier,
* Extra-hepatic metastases other than adenopathies of the hilum smaller than 2 cm,
* \>70% tumor invasion of the liver,
* Bilirubinemia ≥ 35 µmol/L,
* A Severe underlying biliary pathology:
* Bile duct anomaly (stent, dilation) Cirrhosis of biliary origin,
* Women of childbearing age without contraception
* Pregnant or nursing women
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02582034
Study Brief:
Protocol Section:
NCT02582034