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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT05903456
Eligibility Criteria:
Inclusion Criteria:
1. Between the ages of 18 and 80;
2. Patients with histological/cytological confirmed hepatocellular carcinoma.
3. HCC patients eligible for China liver cancer staging (CNLC) Stage IIIa, which cannot be resectable, are not suitable for radical treatment.
4. According to the RECIST v1.1 standard, there must be at least one measurable lesion on the upper abdominal enhanced CT or MRI.
5. Child-Pugh grade A or B;
6. ECOG physical condition score is 0 or 1;
7. Suitable for the indications of TACE surgery and chemotherapy drugs prescribed in advance by the research center, without any contraindications.
8. Regular antiviral therapy should be given if HBV or HCV infection is present.
9. Life expectancy is more than 3 months
10. Able to swallow and absorb oral tablets;
11. Appropriate organ function with the following laboratory test values obtained within 7 days prior to therapeutic use:
12. (hemoglobin value ≥80g/L, neutrophil count ≥2.5×109/L, platelet count ≥75×109/L, serum total bilirubin ≤2× upper limit of normal (UNL), aspartic transferase ≤2×UNL, alanine transferase ≤3×UNL, serum creatinine ≤1.5×UNL)
13. Manageable blood pressure
14. Women of childbearing age must already be using reliable contraception or have had a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an effective method of contraception during the trial period and within 2 months after the last drug administration. Male subjects whose partners are women of childbearing age should use effective methods of contraception during the trial period and within 2 months after the last dose;
15. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion Criteria:
1. Formation of portal vein main cancer thrombus or extensive cancer thrombus.
2. HCC was treated with local treatment of existing lesions (e.g., TACE, ablation, particle, TARE, hepatic arterial infusion chemotherapy, or radiotherapy).
3. Patients who have previously received targeted or immunoreactive anti-tumor therapy for HCC and chemotherapy need to be desensitized for more than one month.
4. Subjects were unable to perform enhanced CT or MRI scans of the liver.
5. Have a history of liver transplantation or are currently candidates for liver transplantation.
6. Patients at high risk for esophageal or gastric variceal bleeding or unproven severe variceal bleeding within the last 3 months.
7. Have bleeding or thrombotic disease or are receiving thrombolytic therapy
8. Study clinically significant hemoptysis or tumor hemorrhage of any cause within 2 weeks prior to initial administration of the intervention.
9. Study of significant cardiovascular impairment in the 12 months prior to initial administration, such as a history of congestive heart failure above NYHA Grade II (Appendix 12), unstable angina, myocardial infarction or cerebrovascular stroke, or arrhythmias associated with hemodynamic instability.
10. There was clinically significant ascites on physical examination, which could not be controlled by drugs.
11. Known to be allergic to any component of icartin soft capsules and lenvatinib preparation.
12. Pregnant or lactating female patients.
13. Other conditions in which participation in the study is not appropriate according to the investigator's judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05903456
Study Brief:
Protocol Section:
NCT05903456