hepatocellular carcinoma
Conditions
Interventions
Trial Arm:TACE combined with Icaritin and TKI
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age = 18 years, male or female; 2. primary hepatocellular carcinoma confirmed by clinical diagnostic criteria and/or by histopathological or cytological examination; 3. no previous systemic therapy; 4. CNLC stage IIa-IIIb; 5. Child-Pugh = 7 points; 6. ECOG PS: 0-1; 7. presence of at least one measurable lesion according to RECISTv1.1 or mRECIST criteria; 8. be suitable for the pre-specified indications for TACE surgery and chemotherapeutic agents at the study centre without any contraindications; 9. Have normal organ function and meet the following criteria for laboratory tests within 7 days prior to the start of treatment: Haematology: neutrophil count = 1.5 × 10^9/L, platelet count = 50 × 10^9/L, haemoglobin = 80 g/L, serum albumin = 30 g/L; before enrolment, leukocytes = 2.0 × 10^9/L, with no tendency to haemorrhage; blood biochemistry: total bilirubin = 2ULN, AST and ALT = 3ULN, alkaline phosphatase (ALP) = 2.5ULN; myocardium = 2.5ULN; blood glucose = 2.5ULN. 2.5ULN; creatinine =1.5×ULN and creatinine clearance =50ml/min; 10. Receive regular antiviral therapy if HBV or HCV infection exists; 11. Have good swallowing function; 12. have a life expectancy of ?3 months; 13. males and females of gestational age must agree to use adequate contraception throughout the study and for 3 months after the end of treatment; 14. Subjects voluntarily enrolled in the study, willing to sign an informed consent form, and expected to have good compliance with the study protocol.
Exclusion criteria
Exclusion criteria: 1. patients who are not suitable for TACE treatment; 2. Previous histologically/cytologically confirmed fibroplaque-containing hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 3. patients who have received previous systemic therapy for HCC, including chemotherapeutic agents, targeted drug therapy such as sorafenib, lenvatinib, regorafenib, immunomodulators such as anti-PD-1, anti-PD-L1, anti-CTLA-4, and modern Chinese herbal medicines with anti-tumour indications, topical treatments, and patients who are receiving any other investigational drugs, except for antiviral therapy; 4. There are contraindications to interventional therapy, such as severe cirrhosis, more than moderate amount of ascites, and liver function Child C class; 5. Significant cardiovascular compromise within 12 months prior to the first dose of study drug: e.g., history of congestive heart failure, unstable angina, myocardial infarction, or cerebrovascular accidental stroke in New York Heart Association (NYHA) class II or higher, or arrhythmia associated with haemodynamic instability; prolongation of the corrected QT (QTc) interval by >480ms; 6. Any surgical procedure within the last 28 days; 7. bleeding from ruptured oesophageal or gastric varices within the last 2 weeks, or unproven severe varices and patients at high risk of bleeding in the judgement of the investigator; 8. the presence of bleeding or thrombotic disorders or undergoing thrombolytic therapy, coagulation disorders; patients who, in the opinion of the investigator, are not suitable for participation in this study; 9. clinically significant haemoptysis or tumour bleeding of any cause within 2 weeks prior to the first administration of the study intervention; 10. patients with uncontrolled epilepsy, history of central nervous system disease or psychiatric disorders, hypertension The investigator will determine whether clinical severity prevents signing of informed consent or affects patient adherence to oral medication; 11. active autoimmune disease requiring systemic therapy within the past 2 years; 12. have a previous history of liver transplantation or are currently a candidate for liver transplantation; 13. clinically significant ascites on physical examination that cannot be controlled with medications; 14. Uncontrolled active hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV) infection; history of active tuberculosis; 15. Pregnant or lactating female patients, or those who are unwilling to use contraception during the trial; 16. Known hypersensitivity to the components of the Epimedium Soft Capsule preparation, the components of the Targeted Pharmaceutical Preparation, or iodine contrast agents; 17. Diseases or conditions that are suspected to cause contraindications to the use of the drug, or to affect the reliability of the study results, or to place the patient at a high risk of treatment complications, or to affect the patient's adherence to the trial medication; 18. in the opinion of the investigator is not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Overall survival (OS);Duration of ongoing remission (DOR);Disease Control Rate (DCR);safety;quality of life; | — |
Countries
China
Contacts
Public ContactXiaoli Zhu
The First Affiliated Hospital of Soochow University
Outcome results
None listed