Hepatocellular carcinoma
Conditions
Interventions
experimental group:Sequential doxorubicin-eluting beads of iodized oil TACE
control group:doxorubicin-eluting beads TACE
Sponsors
Third Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 75 (male or female); 2. The expected survival time of the patient is at least 12 weeks; 3. Child-pugh A or B grade of liver function; 4. BCLC stage B; 5. ECOG physical condition score = 3.0 * 10^9/L; Hemoglobin >= 8.5g/ dL; Platelet count >= 50 * 10^9/L; ALT and AST were less than 3 times of the normal upper limit.Albumin >= 3.0g/ dL; Total bilirubin <= 3mg/ dL; The international standard ratio of prothrombin time (INR) <=2.3 or prothrombin time (PT) did not exceed the upper limit of the normal control for 3 seconds.Amylase and lipase were less than 1.5 times of the normal upper limit.Serum creatinine is less than 1.5 times the normal upper limit. 7. The patient and/or family members agree to participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Unconfirmed diagnosis and stage of HCC according to diagnostic criteria of hepatocellular carcinoma. 2. Is known or suspected to be allergic to the drug under test (e.g. iodized oil) or to any drug given in connection with this test. 3. BCLC Stage 0, Stage A, stage C and Stage D. 4. Tumor volume accounting for 70% or more of the whole liver. 5. Child-pugh grade of liver function Grade C. 6. ECOG physical condition score > 2. 7. Severe heart disease, such as: congestive heart failure > New York heart association (NYHA) class II, active coronary artery disease (patients with myocardial infarction 6 months prior to enrollment may be enrolled), arrhythmias requiring treatment (except for B receptor-blockers, calcium antagonists, or digoxin). 8. Uncontrolled hypertension (diastolic blood pressure cannot be controlled below 90mmHg even after treatment with three antihypertensive drugs. 9. Active clinical severe infection (> level 2 nci-ctcae 4.0 version). 10. Presence of active pulmonary tuberculosis, or inability to exclude pulmonary lesions of old pulmonary tuberculosis. 11. Known tumors of the central nervous system, including brain metastases. 12. Clinically significant gastrointestinal bleeding within 30 days before enrollment. 13. Chronic renal failure. 14. Pregnant or breast-feeding patients. 15. Any unstable condition or condition that may jeopardize the patient's safety and his/her compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactBai Mingjun
Third Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed