Primary liver cancer
Conditions
Interventions
experimental group:Lipiodol chemotherapeutic drug emulsion sequential combined with Callispheres drug-loaded microsphere hepatic artery chemoembolization
Control group:Callispheres drug-loaded microspheres hepatic artery chemoembolization
Sponsors
The Affiliated Tumor Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with primary liver cancer confirmed by imaging and pathology; 2. Patients aged from 18 to 75 (male or female); 3. For patients whose number of target lesions is less than or equal to 3, the sum of lesion diameter is more than 5 cm and less than 10 cm; 4. Laboratory indexes should meet the following standards: (1) WBC count >= 3.0 x 10^9 / L (2) Hemoglobin >= 8.5g/dl (3) Platelet count >= 50 x 10^9 / L (4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 3 times of the upper limit of normal (5) Albumin >= 3.0g/dl (6) Total bilirubin is less than 3 times of the upper normal limit (7) The international normalized prothrombin time ratio (INR) < = 2.3 or the prothrombin time (PT) did not exceed the upper limit of normal control for 3 seconds. (8) Serum creatinine is less than 1.5 times of the upper normal limit 5. BCLC stage was A4 and B; 6. Patients with primary liver cancer who are not suitable for surgery or unwilling to accept surgery; 7. Patients with child Pugh grade a liver function; 8. Patients with ECoG score of 0-1; 9. Patients without vascular invasion and extrahepatic metastasis; 10. Patients with an expected survival period of at least 12 weeks; 11. The patients and / or family members agree to participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with malignant tumor of other parts; 2. Patients with unstable systemic diseases or uncontrolled infections; 3. Pregnant or lactating patients; 4. Patients with chronic renal failure; 5. Any unstable condition or situation that may endanger the patient's safety and his / her compliance with the study; 6. Patients who have received surgery, chemotherapy, radiotherapy, immunotherapy and traditional Chinese medicine treatment in the past; 7. Patients with clinically significant gastrointestinal bleeding within 30 days before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactHe Dongfeng
The Affiliated Tumor Hospital of Harbin Medical University
Outcome results
None listed