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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT01997957
Eligibility Criteria:
Inclusion Criteria:
* Signing the informed consent form;
* Diagnosed with HCC
Patients with hepatic cirrhosis must comply with AASLD (American Association for the Study of Liver Diseases) diagnostic criteria:
Typical radiological examination (ultrasonography, CT or MRI) manifestations: dynamic enhanced examination shows arterial-phase rapid heterogeneous enhancement and reduced venous-phase or delayed-phase rapid enhancement of space occupation in liver;
* If the diameter of space occupation in liver is ≥2cm, the diagnosis can be established if any of radiological examinations shows the above HCC characteristics;
* If the diameter of space occupation in liver is 1-2cm, the diagnosis can be established only when two radiological examinations show the above HCC characteristics;
* If the diameter of space occupation in liver is≤1cm, histopathological examination is needed for establishing the diagnosis.
Histopathological examination is needed for establishing the diagnosis for patients without hepatic cirrhosis.
* Stage Barcelona C
* Grade A or B Child-Pugh score
* ECOG PS score is 0-1
* At least one measurable focus in liver according to (M) RECIST 1.0 criteria
* Male or female, age\>18
* Can orally take drugs
* Anticipated survival≥12 weeks
* Pregnancy test of women at child-bearing ages must be negative within the 7 days before treatment
* Male or female patients included must take effective contraceptive measures during the study period and within 4 weeks after completion of the study
* Within the 7 days before inclusion, bone marrow, liver and kidney functions must satisfy the following requirements:
* Hemoglobin≥ 90 g/L
* Absolute neutrophil count (ANC) \>1,500/mm3
* Platelet count≥ 80x109/L
* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 times the upper normal limit (UNL)
* Total bilirubin \< 3UNL
* Alkaline phosphatase \< 4UNL
* Serum creatinine \< 1.5 UNL
* Amylase and lipase \< 2 UNL
* INR\<2.3 or PPT\< 1.5 UNL (Patients who are accepting Warfarin or heparin anticoagulant therapy may be included if no evidence is available proving the above indicators are abnormal, but intense monitoring must be exercised. Tests shall be carried out at least once per week until stable INR.)
Exclusion Criteria:
* Early or middle-stage primary HCC
* Any contraindication of TACE therapy
* Known hepatofugal blood flow
* Known portal-systemic shunt
* Abnormal coagulation test (PLT\<6000/mm3, thrombogen activity\<50%)
* Renal failure or renal insufficiency necessitating dialysis
* Serious atherosclerosis
* Foci having undergone local treatment (e.g. resection, RFA, PEI or argon-helium cryoablation) cannot be used as the target foci
* Local therapy or systemic chemotherapy within 4 weeks before inclusion or during the study period
* Acute toxic reaction of CTC grade AE2 or above in any local treatment before inclusion
* History of heart diseases:
* Congestive heart failure of NYHA grade 2 above
* Symptomatic coronary artery disease
* Arrhythmia needing treatment with β blockers or drugs other than digoxin
* uncontrollable hypertension
* HIV infection or AIDS-related diseases
* Serious active infections other than hepatitis B and hepatitis C (NCI-CTCAE 4.0 grade 2 above)
* Gastrointestinal hemorrhage event within 4 weeks before inclusion
* Thrombogenesis or embolism event within 6 months before inclusion, e.g. cerebral vascular accidents (including TIA), deep venous thrombogenesis or pulmonary embolisms
* Past or present history of concomitant tumors completely different from HCC in primary lesions or histology, excluding head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder carcinoma (Ta, Tis, T1) and tumors having been cured 3 years before inclusion
* Drug abuse, or psychological or mental diseases that may interfere with the study compliance
* Known or suspected allergy to the study drug or concomitant medications
* Contraindications of S-1
* Pregnancy or lactation
* Any disease that may affect evaluation of the study drug
* Any instability or condition that may impair the patient's safety and compliance in the study
* Gastrointestinal diseases affecting absorption or pharmacokinetics
* Conditions restricting the patient from taking drugs orally, including serious upper gastrointestinal obstruction
* Having accepted TACE before inclusion
* Having taken S-1 before inclusion
* Having accepted liver radiotherapy before inclusion or during the study period
* Having accepted biological regulators, e.g. G-CSF, within the 3 weeks before inclusion
* Having accepted autologous bone marrow transplantation or stem cell transplantation within 1 year before inclusion
* History of homoplastic transplantation
* Any drug that may affect absorption or pharmacokinetics of the study drug
* Poor compliance considered by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01997957
Study Brief:
Protocol Section:
NCT01997957