Hepatocellular carcinoma
Conditions
Interventions
Group A:Idarbicin 20mg via Hepatic arterial infusion
Group B:Sorafenib tablets, 400mg, Oral, twice daily
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. Strictly comply with the guidelines for diagnosis and treatment of primary liver cancer (2019 edition) or confirmed by histopathology or cytology of recurrence/metastasis HCC , patient can't accept palliative surgery or radiation therapy, and have at least one measurable lesions (according to mRECIS standard which requires the measurable lesions length up to 10 mm in diameter or swollen lymph nodes up to 15 mm in diameter under spiral CT scanmRECIST see Attathment 1) 3. Child-Pugh staging stage A or BChild-Pugh staging see Attachment 2BCLC stage C Barcelona Clinical HCC staging2010 see Attachment 3; 4. One week before inclusion ,ECOG PS score1-2ECOG score see Attachment 4; 5. Anticipated Survival >= 12 weeks; 6. Massive hepatocellular carcinoma patientThe tumor occupies less than 70% of the entire liver; 7. Major organs function normally: (1) Blood count (No blood transfusion, no usage of G-CSF and no drug correction within 14 days prior to screening): a) HB >= 90 g/L; b) ANC >= 1.0 * 10^9/L; c) PLT >= 50 * 10^9/L. (2)biochemistry (No infusion of ALB within 14 days prior to screening): a) ALB >= 29 g/L; b) ALT and AST < 5*ULN; c) TBIL <= 1.5*ULN; d) ScR <= 1.5*ULNA.
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%; 5Suffering ? 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 |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ;TTP;DCR;ORR; | — |
Countries
China
Contacts
Public ContactLi Jiaping
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed