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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT03511703
Eligibility Criteria:
Inclusion Criteria:
1. Age: ≥18 years old;
2. HCC diagnosed by histopathology or cytology (including pathological margin positive lesions, residual positive lesions after DSA angiography, combined vascular tumor thrombus and/or biliary tumor thrombus, pathologically confirmed lymph node metastasis, and liver The tumor ruptured, adjacent organs were invaded, the number of tumors was ≥ 3, AFP did not fall to normal range at 2 months after operation, and pathologically confirmed vegf + or patients with microvascular invasion.
3. Child-Pugh Liver Function Rating: Grade A or better Grade B (≤ 7 points);
4. ECOG PS score: 0-1 points;
5. Expected survival period ≥ 12 weeks;
6. The normal function of the major organs is the following:
(1) Blood tests: HB≥90 g/L; ANC≥1.5×109/L; PLT≥60×109/L; (2) Biochemical tests: ALB ≥29 g/L; ALT and AST\<2.5ULN; TBIL ≤ 2ULN; Creatinine ≤1.5ULN; (Child-Pugh can only have 2 points for both albumin and bilirubin) 7. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment; 8. Subjects voluntarily joined the study, signed informed consent, and adhered well to follow-up.
Exclusion Criteria:
1. Have received systematic treatment in the past;
2. Hepatobiliary cell carcinoma and mixed cell carcinoma and fibrous lamellar cell carcinoma are known; in the past (within 5 years) or with other untreated malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
3. Patients who are preparing for liver transplantation (except those who have previously undergone liver transplantation);
4. Ascites with clinical symptoms, which require therapeutic paracentesis or drainage;
5. People with high blood pressure who are unable to fall within the normal range after treatment with antihypertensive drugs (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg);
6. Arrhythmia with grade II or higher myocardial ischemia or myocardial infarction and poor control (including QMS interval men ≥450 ms, women ≥470 ms);
7. In accordance with NYHA criteria III-IV heart failure or cardiac ultrasound examination: LVEF (left ventricular ejection fraction) \<50%;
8. Has a variety of factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption);
9. In the past 6 months, there was a history of digestive tract bleeding or a clear tendency to gastrointestinal bleeding. For example, esophageal varices, local active ulcer lesions, fecal occult blood ≥ (++) may not enter the group. If fecal occult blood (+) requires gastroscopy;
10. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study;
11. Coagulation abnormalities (INR\> 1.5 or prothrombin time (PT)\> ULN + 4 seconds) with a tendency to hemorrhage or receiving thrombolytic or anticoagulant therapy;
12. Patients with central nervous system metastases or known brain metastases have occurred;
13. Patients with objective evidence of previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impaired lung function;
14. Urine routine showed urinary protein ≥ ++ or confirmed 24-hour urinary protein quantification\> 1.0 g;
15. Was treated with potent CYP3A4 inhibitors within 7 days before participating in the study or was treated with potent CYP3A4 inducer within 12 days prior to study participation;
16. Pregnancy or breastfeeding women; those with fertility who are unwilling or unable to take effective contraceptive measures;
17. There is a history of mental illness or abuse of psychotropic substances;
18. Patients with bone metastases who have received palliative radiotherapy (radiotherapy area\> 5% bone marrow area) within 4 weeks before participating in the study;
19. Joint HIV-infected patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03511703
Study Brief:
Protocol Section:
NCT03511703