gynecological tumors
Conditions
Interventions
Drug microspheres:drug-loaded microsphere embolization (d-tace)
TACE group:Iodine oil, gelatin sponge pellet treatment
Sponsors
The First Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, aged 18 or above, life expectancy over 12 weeks. 2. Intrahepatic recurrence was confirmed by CT/MRI/ ceus after surgical resection of liver cancer or/and radiofrequency ablation, and one of the following conditions was met: 2.1 single lesion >5cm; 2.2 2-3 lesions, at least 1 lesion >3cm; 2.3 there are 4 or more lesions without limiting the minimum diameter. 3. Child Pugh A/B (7 points), no need for treatment of pleural effusion and hepatic encephalopathy; 4. The ECOG behavioral status score was 0-1; 5. Did not receive TACE treatment after recurrence; 6. Adequate hepatorenal function with appropriate laboratory parameters (untreated) within 7 days of randomization HGB=9.0g/dl, neutrophil=1,500/mm3, PLT=50x10^9/L, serum ALB=28g/L, TBIL<2 mg/ dl, ALT, AST< 5 times normal upper limit, Bun, Cr<1.5 times normal upper limit, INR<1.7 or PT extension <4s; 7. Patients and/or family members agree to participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Main portal vein invasion (non-main branch tumor thrombus invasion can be included in the group); 2. Invasion of large blood vessels (inferior vena cava, hepatic vein);Diffuse metastases; 3. Biliary obstruction caused by tumor invasion of biliary tract; 4. Extrahepatic diffusion; 5. Portal shunt or hepatic arteriovenous fistula; 6. Congestive heart failure > New York heart association (NYHA) grade 2;Has uncontrollable high blood flow Pressure; 7. Renal failure or inadequate renal function, requiring blood or peritoneal dialysis; 8. The target lesions were treated with TACE, molecular targeted drug therapy, radiotherapy, chemotherapy and immunotherapy before enrollment; 9. Patients with severe pulmonary dysfunction; 10. Tumor volume exceeded 70% of liver volume; 11. Upper gastrointestinal bleeding or clear tendency of gastrointestinal bleeding occurred within 4 weeks before the start of the experiment; 12. Patients within 30 days after major surgery; 13. Patients and/or family members do not agree to participate in the clinical trial; 14. Pregnant and lactating women, or female patients with family planning during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;TTP;TTUP;Time of extrahepatic metastasis;ORR; | — |
Countries
China
Contacts
Public ContactZhang Hui
The First Affiliated Hospital of the Army Medical University
Outcome results
None listed