Hepatocellular carcinoma
Conditions
Interventions
Group A:DCB +IDARUBICIN
Group B:DCB +EPIRUBICIN
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients should meet all the following criteria before participating in the trial: 1. Aged >= 18 years; 2 .Patients with recurrence/metastasis HCC who met clinical diagnostic criteria (2019)or have been diagnosed by histopathology or cytological examination and were unable to undergo palliative surgery or radiotherapy and have at least one measurable lesion(according to the requirements of RECIST version 1.1, the long diameter of the measured lesion in spiral CT scan was >= 10mm or the short diameter of enlarged lymph node was >= 15mm); 3. Child-pugh liver function Rating: A level or B level; BCLC Staging as B period; 4. Before join in the group 1 weeks ECOG PS Rating: 0 score; 5. Estimated Lifetime >= 12 Week; 6. Patients with massive liver cancer, the proportion of tumors in the whole liver occupied = 1.0x109/L; c. PLT >= 50x109/L; (2) Biochemical Examination(no ALB input within 14 days): a. ALB >= 29 g/L; b. ALT and AST < 5 * ULN; c. TBIL <= 1.5 * ULN; d .Cr <= 1.5 * ULN.=
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria were excluded from the study: 1. Hepatobiliary cell carcinoma and mixed cell carcinoma are known; previous (5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ; 2. Patients preparing for liver transplantation (except for those who have previously undergone liver transplantation); 3. Rupture and hemorrhage of liver cancer and hepatic artery-portal vein shunt caused portal hypertension hemorrhage. 4. Patients with massive liver cancer, the proportion of tumors in the whole liver occupied >= 70%; 5. Suffering II above-level myocardial ischemia or myocardial infarction, control of poor arrhythmia (including QTC inter-phase male >= 450 ms, female >= 470 ms); 6. Follow NYHA Standard III ~ IV grade heart insufficiency or heart color Doppler ultrasonography: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendencies or undergoing thrombolysis or anticoagulant therapy; 9. Patients who have undergone central nervous system metastasis or known brain metastases; 10. Patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment; 11. Urine proteins are routinely shown >= ++ or confirmed 24 hour urine protein ration > 1.0 g ; 12. Pregnant or lactating women who are not willing or unable to take effective contraceptive measures; 13. Patients with bone metastases received palliative radiotherapy (radiotherapy area > 5% bone marrow region) 4 weeks before participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;TTP;DCR;ORR; | — |
Countries
China
Contacts
Public ContactLi Jiaping
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed