Health Condition 1: null- Hepatocellular Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent provided 2. Aged >=18 years 3. AASLD criteria for diagnosis of HCC. 4. BCLC stage A and B. 5. ECOG performance status 0 6. Hemoglobin >= 9 g/dl, neutrophils >=1,500/mm3 and platelets >=50,000/mm3 7. Normal kidney function tests: Serum creatinine 8. Bilirubin 9. Child-Pugh class A-B
Exclusion criteria
Exclusion criteria: 1. Extra hepatic metastases 2. Previously treated HCC 3. Advanced liver disease with a Child-Pugh score C or active gastrointestinal bleeding or encephalopathy or refractory ascites 4. Pregnant or breastfeeding women 5. Allergy to contrast agents 6. Contraindication to hepatic artery catheterization, such as severe peripheral arterial disease precluding catheterization 7. Mental illness or other psychological disorder affecting the informed consent 8. Patient unable or unwilling to comply with the treatment and follow-up required by the study 9. Unable to take oral medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of tumour after intervention as assessed by mRECIST criteriaTimepoint: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Median overall survival time since randomization Adverse Events during therapy Tumor Progression-free survival Quality of Life Cost benefit ratioTimepoint: 12 months 12 months 12 months 12 months 12 months | — |
Countries
India
Contacts
All India Institute of Medical Sciences