Hepatocellular carcinoma
Conditions
Interventions
DEB-TACE:DEB+ idarubicin
Sponsors
Sichuan Provincial Academy of Medical Sciences & Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. Hepatocellular carcinoma confirmed by histopathology or clinical diagnosis[European Association for liver research standards]; 3. Estimated Lifetime >= 3 months; 4. At least one measurable lesion (according to the requirements of mRECIST); 5. Some patients with BCLC stage B or C, or Patients with BCLC stage A who can be surgically resected but cannot or will not accept surgery due to other reasons (such as advanced age, severe liver cirrhosis, etc.); 6. Child-Pugh liver function Rating: A level or B level; 7. ECOG score 0 or 1; 8. Patients who have not received chemotherapy, radiotherapy, interventional therapy (including cryotherapy, radio frequency and microwave) for liver cancer in the past; 9. Patients without previous anthracycline chemotherapy; 10. Laboratory examination should met the following criteria: Bone marrow function: ANC >= 1.5x10^9/L; PLT >= 50x10^9/L; HB >=90g/L; Renal function: Cr = 55ml/min; Liver function: TBIL <=3mg/dl; DBIL <=2 ULN; ALT\AST <= 5 ULN; Coagulation function: INR <= 1.5 ULN; 11. Women: Contraception during and within 6 months after treatment; Non lactation; Men: Contraception during and within 6 months after treatment; 12. The subjects volunteered to join the study, signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Any contraindications that are not suitable for TACE treatment [ Standardization of diagnosis and treatment for hepatocellular carcinoma ( 2017 edition ) ]; 2) VP3 and VP4 portal vein tumor thrombus; 3) Intrahepatic metastasis or diffuse HCC with residual liver volume NYHA class II, severe arrhythmia and pericardial effusion of medium and large size; severe atherosclerosis; 7) Bleeding >= CTCAE grade 3 occurred within 4 weeks before enrollment; 8) Patients with severe acute uncontrolled infection or patients with purulent and chronic infection and delayed wound healing, but not include patients with hepatitis requiring routine antiviral treatment; 9) Patients who accepted drug therapy in other clinical trials in the last 4 weeks; 10) Allergy to any test drug; There are contraindications to adriamycin (heart failure); 11) The patients received major surgery within 4 weeks before admission, or the surgical wound was not fully healed; 12) Contraindications of angiography; 13) Pregnancy or lactation; 14) Patients with mental illnesses, the compliance is poor; 15) Other situations in which the researchers believe that patients should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective effective rate and disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Safety; | — |
Countries
China
Contacts
Public ContactPing Xie
Sichuan Provincial Academy of Medical Sciences & Sichuan Provincial People's Hospital
Outcome results
None listed