Hepatocellular carcinoma with portal vein tumor thrombus and hepatic artery-portal vein shunt
Conditions
Interventions
Experimental group:Each treatment cycle is defined as 3 weeks, and the dosing regimen during the treatment period is as follows:
1. HAIC-TAE: HAIC-TAE is performed for up to 6 cycles, every 3 weeks (2
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old and =10 mm, or short diameter of enlarged lymph node >=15 mm) according to RECIST v1.1 requirements); 7. Estimated survival time>=3 months; 8. Laboratory test results within 1 week prior to enrollment meet the following criteria: (1) Neutrophil >=1.0×10^9/L; (2) Leukocyte >=2.0×10^9/L; (3) Platelet >=50×10^9/L; (4) Hemoglobin >=85g/L; (5) Serum ALT, AST=26g/L; (9) Total bilirubin <=1.5×ULN. 9. Females of childbearing potential with a negative pregnancy test result (serum or urine) within 7 days prior to enrollment and non-lactating and agreeing to use effective contraceptive measures during the study period and for 6 months after the end of the study. Males agree to use effective contraception for the duration of the study and for 6 months after its end.
Exclusion criteria
Exclusion criteria: 1.History of severe allergic reaction to iodinated contrast agents; 2.Known diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed-type HCC; 3.Presence of uncontrolled active infections; 4.Current or previous autoimmune diseases, or serious diseases affecting major organs such as the heart, lungs, kidneys, or brain; 5.Clinical significant gastrointestinal bleeding within 30 days prior to the start of the study (except for esophageal-gastric varices patients who have received treatment and are stable); 6.History of other malignant tumors; 7.Inability to comply with follow-up requirements, or currently participating in other clinical trials related to HCC treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate(DCR);Duration of Response(DoR);Time to intrahepatic tumor progression(TTIP);Objective response rate of portal vein tumor thrombosis;Closure rate of APS;Quality of Life (QoL);Safety evaluation;Objective response rate(ORR);Progression-free survival(PFS);Overall survival(OS); | — |
Countries
China
Contacts
Public ContactBoyang Chang
The Third Affiliated Hospital Sun Yat-sen University
Outcome results
None listed