Unresectable HBV-related Hepatocellular Carcinoma,CNLC IIa-IIIa
Conditions
Interventions
treatment group:Treatment is divided into a combined interventional treatment period and a maintenance treatment period. During the combined interventional treatment period, whether to treat TACE-HAIC
Sponsors
Xiamen Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The patient volunteered to participate in the study and signed an informed consent form. (2) =18 and =75 years of age, male or female. (3) Subjects are diagnosed with clinically confirmed HCC, diagnosed with unresectable CNLC stage IIa-IIIa HCC, Child-pughscore A. (4) HBsAg(+)HBV DNA<2000U/mL. (5) Subjects haven't received any systemic treatment for HCC before admission. (6) Subjects enrolled must have at least one measurable lesionaccording to the mRECIST 1.1 standard. (7) ECOG performance status of 0 or 1. (8) Life expectancy =3 months. (9) The main organ's function is normal within 1 week before first dose. (10) Women of childbearing potential must have a negative pregnancy test result within 1 week before the first dose.And use effective contraception during the study period and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: (1) Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and lamellar cell carcinoma; another active malignant tumor except HCC within 5 years or simultaneously. (2) Subjects with cirrhosis in the decompensated phase, Child-Pughscore B or C, obvious signs of hepatic decompensation such as ascites, hepatic encephalopathy, and ruptured esophagogastric fundic variceal vein bleeding. (3) History of severe cardiac disease (e.g., NYHA functional class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia, unstable angina, or other significant cardiovascular disease). (4) A history of autoimmune liver disease, alcoholic liver disease, or co-infection with HCV,HDV,HAV, HEV, HIV or tuberculosis. (5) History of gastrointestinal bleeding or a definite predisposition to gastrointestinal bleeding within 6 months before the start of study treatment. (6) Abdominalfistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months before the start of study treatment. (7) Severe infection within 4 weeks before the start of study treatment. (8) Known to have hereditary or acquired bleeding or thrombosis tendency; Or thrombosis or thromboembolic event within 6 months before the start of study treatment. (9) Subjects have uncontrollable hypertension, despite patients have taken the best drug treatment. (10) Previous or current presence of metastasis to central nervous system. (11) Preparation for or previous organ or allogeneic bone marrow transplantation. (12) The subject has an interstitial lung disease that is symptomatic or may interfere with the discovery or management of suspected drug-related lung toxicity. (13) Use of potent CYP3A4 inducers or inhibitors within 2 weeks before ICF signing. (14) Subjects treated systemically with corticosteroids or other immunosuppressive agents within 14 days before the first dose of study treatment. (15) Treatment with other experimental drugs within 28 days before study treatment. (16) Allergic to IFN or contraindication: acute severe liver damage: ALT = 10 ULN; Pregnant or lactating patients; clear history of autoimmune diseases; serious history of mental illness; history of severe seizures or are currently using anticonvulsants; history of thyroid disease with poor control after standardized treatment; history of severe retinopathy or clinically relevant ophthalmic diseases; (17) Allergic to TACE; allergic to HAIC; history of severe allergy to IFN or any monoclonal antibody; And in addition to the above exclusion criteria, patients who meet any contraindications in the experimental drug instructions; (18) Other circumstances that PI thinks are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;DCR;DOR;Survival rate; | — |
Countries
China
Contacts
Public ContactZhengyu Yin
Xiamen Hospital of Traditional Chinese Medicine
Outcome results
None listed