Hepatocellular carcinoma
Conditions
Interventions
A group:HAIC plus targeted therapy
B group:Only targeted therapy
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with recurrent hepatocellular carcinoma after liver transplantation are not suitable for or refuse surgical resection, local ablation and other therapeutic treatments. 2. According to the RECIST1.1 standard, there is at least one measu;able intrahepatic lesion; 3. The tumor do not invade the main portal vein, hepatic artery and other large vessels; 4. The patients are not complicated with other primary malignant tumors; 5. There are no following contraindications for HAIC treatment: (1) severe liver dysfunction (Child-Pugh C grade), or obvious jaundice, hepatic encephalopathy, refractory peritoneal effusion or hepatorenal syndrome; (2) the function of blood coagulation decreased seriously and could not be corrected; (3) complicated with active hepatitis or severe infection and can not be treated at the same time; (4) the tumor had extensive distant metastasis and the estimated survival time was less than 3 months; (5) cachexia or multiple organ failure; (6) peripheral white blood cell and platelet decreased significantly, white blood cell count 2mg/dl or creatinine clearance < 30ml/min; (8) severe abnormality in electrocardiogram and cardiac enzyme examination; 6. ECOG score 0-2; 7. Patients do not receive other anti-tumor therapy before entering the group; 8. The patients who are older than 18 and younger than 75 and have no sex restriction; 9. Patients who agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with the contraindications of HAIC treatment mentioned above; 2. Patients with positive human immunodeficiency virus; 3. Patients who are known or suspected to be allergic to research preparations or any preparations related to this test; 4. Patients with ventricular arrhythmias who need antiarrhythmic treatment; 5. Patients with significant gastrointestinal bleeding within 30 days before the start of the study; 6. Patients with severe bleeding tendency, unhealed wound, ulcer or fracture; 7. The researchers believe that subjects may not be able to complete this study or may not be able to comply with the requirements of this study (for management or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival rate;Overall survival;Progression-free survival;Objective response rate;Disease control rate;Time to Progression;Duration of Response;Duration of Disease Control; | — |
Countries
China
Contacts
Public ContactJian Li
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed