hepatocellular carcinoma
Conditions
Interventions
experimental group-1:cTACE(TP21 + lipiodol)
experimental group-2:HAIC(TP21)+cTACE(pirubicin hydrochloride + lipiodol)
control group:cTACE(pirubicin hydrochloride + lipiodol)
Sponsors
Zhongda Hospital, Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years adults, with an estimated survival period of no less than 3 months; 2. Pathological and/or clinical diagnosis as hepatocellular carcinoma; 3. Child-Pugh stage A or B, with an ECOG PS score of 0-2; 4. Stage Ib, IIa, or IIb (guidelines for diagnosis and treatment of primary liver cancer in China-2017 edition); 5. With at least one measurable lesion; 6. Never underwent TACE, or new lesion after the curable treatments such as surgery resection or ablation 7. Laboratory inspections before enrollment meets the following standards: hemoglobin >= 80g/L; platelet count >= 60x10^9/L; white blood cell count>=3x10^9/L; albumin>=30g/L; alanine aminotransferase<=3 ULN; aspartate aminotransferase<=3 ULN; total bilirubin<=2 ULN; creatinine<=1.5 ULN 8. Female patients are not pregnant, do not breastfeed, apply effective contraception, and agree to the trial period and 12 months thereafter; No pregnancy, male patients agree that their spouse is not pregnant during the trial and 12 months thereafter; 9. Willing to participate in this study and voluntarily signing the informed consent.
Exclusion criteria
Exclusion criteria: 1. Be allergic to the iodine products, epirubicin hydrochloride, or related auxiliary materials; 2. Diffuse (accounts for more than 70% of total liver) or hypovascular hepatocellular carcinoma; 3. Tumor thrombus in the trunk or the first branch of portal vein; 4. Bile duct tumor invasion; 5. Coexisting other tumor(s), arteriovenous shunt, or extrahepatic metastasis 6. Underwent other anti-tumor treatments, including chemotherapy, radiotherapy, immunotherapy, etc., within 4 weeks before enrolling; 7. Cachexia or multiple organ failure, with an estimated survival time of <3 months; 8. Uncorrectable coagulation abnormalities; 9. Positive human immunodeficiency virus antibodies; 10. Positive treponema pallidum antibody; 11. Joining other clinical studies within 6 months before enrolling; 12. Other medical or psychological conditions prevent enrolling or signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of Response;progress free survival; | — |
Countries
China
Contacts
Public ContactTeng Gaojun
Zhongda Hospital, Southeast University
Outcome results
None listed