Health Condition 1: C220- Liver cell carcinoma Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Transarterial chemoembolization and Stereotactic radiotherapy: Combination of Transarterial chemoembolization, Stereotactic radiotherapy and oral Lenvatinib tablets followed by living d
Sponsors
Institute of liver disease and transplantation
Eligibility
Inclusion criteria
Inclusion criteria: a. Age: 18-70 years b. Eastern cooperative oncology group (ECOG) performance status: 0-2 c. Child Pugh A and B status d. HCC of any size and any number e. Portal vein tumor thrombus or invasion (Vp1-4) f. No extra-hepatic disease by CECT/MRI and 18FDG/68GaPET scan
Exclusion criteria
Exclusion criteria: a. Poor performance status (ECOG >2) b. Child Pugh C status c. Mixed tumors such as hepatocholangiocarcinoma d. Previous treatment for HCC e. Extra-hepatic metastatic disease f. Hepatic vein or inferior vena cava involvement g. People unfit for LDLT independent of the liver disease due to poor cardiopulmonary status h. Non-availability of living related liver donor i. Consent withdrawn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients undergoing/eligible for living donor liver transplantation at 6 months after downstagingTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| • One- and 3-year overall survival and recurrence-free survival after LT • Progression-free survival at 3 months, 6 months and 1 year in non-LT patients • Radiological tumor response by RECIST1.1 criteria • Predictors of tumor response to downstaging therapy • Rate of post LDLT recurrence • Adverse events to TACE/SBRT/Lenvatinib/Pembrolizumab according to common terminology for adverse events version 5.0 • Pattern of tumor recurrence after LDLT Timepoint: 6 months, 1 year and 3 years | — |
Countries
India
Contacts
Public ContactDr Muthukumarassamy Rajakannu
Dr Rela Institute and Medical Centre and Bharath Instiute of higher education and research
Outcome results
None listed