| CTRI Number |
CTRI/2024/03/064473 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on patients with advanced liver cancer who have received chemotherapy and have undergone liver transplant |
|
Scientific Title of Study
|
Living donor liver transplant in advanced hepatocellular carcinoma (HCC) down staged with systemic therapy with or without locoregional therapy (LRT) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Alisha Chaubal |
| Designation |
Principal Consultant Hepatology and Liver Transplant Physician |
| Affiliation |
Nanavati Max Super Speciality Hospital |
| Address |
Nanavati Max Institute of Liver Intestine & Pancreas Sciences
Nanavati Max Super Speciality Hospital
S.V.Road
Vile Parle west
Mumbai 400056
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9967321108 |
| Fax |
|
| Email |
alishachaubal@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Alisha Chaubal |
| Designation |
Principal Consultant Hepatology and Liver Transplant Physician |
| Affiliation |
Nanavati Max Super Speciality Hospital |
| Address |
Nanavati Max Institute of Liver Intestine & Pancreas Sciences
Nanavati Max Super Speciality Hospital
S.V.Road
Vile Parle west
Mumbai 400056
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9967321108 |
| Fax |
|
| Email |
alishachaubal@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Alisha Chaubal |
| Designation |
Principal Consultant Hepatology and Liver Transplant Physician |
| Affiliation |
Nanavati Max Super Speciality Hospital |
| Address |
Nanavati Max Institute of Liver Intestine & Pancreas Sciences
Nanavati Max Super Speciality Hospital
S.V.Road
Vile Parle west
Mumbai 400056
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9967321108 |
| Fax |
|
| Email |
alishachaubal@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Nanavati Max Institute of Liver Intestine & Pancreas Sciences
Nanavati Max Super Speciality Hospital
S.V.Road
Vile Parle west
Mumbai 400056
|
|
Primary Sponsor
Modification(s)
|
| Name |
Nanavati Max Institute of Liver Intestine Pancreas Sciences |
| Address |
Nanavati Max Super Speciality Hospital
S.V.Road
Vile Parle west
Mumbai 400056
|
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhindran S |
Amrita Institute of Medical Sciences |
Department of Gastrointestinal Surgery and Solid Organ Transplantation
F Block 2nd floor
Ponekkara P.O. Edappaly
Ernakulam
Kerala 682041
Ernakulam
KERALA |
9388623851
sudhi@aims.amrita.edu |
| Dr Anand Kulkarni |
Asian Institute of Gastroenterology Hospitals |
No 136 Plot no 2 3 4 5 survey
1 Mindspace road
Gachibowli
Hyderabad
Telangana 500032
Hyderabad
TELANGANA |
8553322434
anandvk90@gmail.com |
| Dr Sonal Asthana |
Aster CMI Hospital Bangalore |
Integrated Liver Department
Room no. 5
Ground floor
43 2 new airport road NH7 outer ring road
Sahakarnagar
Bengaluru
Karnataka 560092
Bangalore
KARNATAKA |
9686976379
sonal@transplantationliver.com |
| Professor Mohamed Rela |
Dr Rela Institute and Medical Centre |
Institute of liver disease and transplantation
No 7
CLC Works Road
Chromepet
Chennai 600044
Chennai
TAMIL NADU |
9884173583
ashwinrammohan@gmail.com |
| Dr Mettu Srinivas Reddy |
Gleneagles Global Health City |
Deaprtment of liver transplantation surgery
#439 Cheran nagar Perumbakkam Chennai 600100
Chennai
TAMIL NADU |
9840054648
smettu.reddy@gmail.com |
| Dr Sanjiv Saigal |
MAX Super Speciality Hospital, Saket (A unit of MAX Healthcare Institute Limited) |
1 Press Enclave Road
Saket New Delhi 110017
New Delhi
DELHI |
9811552928
sanjivsaigal@hotmail.com |
| Dr Prashant Bangui |
Medanta The Medicity |
Institute of Liver Transplantation and regerative medicine
Room no. 9
14th floor OPD
Sector 38
Gurgaon
Haryana 122001
Gurgaon
HARYANA |
9871299733
pbhangui@gmail.com |
| Dr Alisha Chaubal |
Nanavati Max Super Speciality Hospital |
Nanavati Max Institute of Liver Intestine & Pancreas Sciences
Nanavati Max Super Speciality Hospital
S.V.Road
Vile Parle west
Mumbai 400056
Mumbai
MAHARASHTRA |
9967321108
alishachaubal@gmail.com |
| Dr Sheetal Mahajani |
Sahyadri Clinical Research and Development Centre |
A unit of Sahyadri Hospitals PVT LTD
33/34B Makarand Bhave Path
Erandawane
Pune 411004
Pune
MAHARASHTRA |
9822912080
drsheetalmahajani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Aster IEC Institutional Ethics Commitee |
Approved |
| Ethics Committee Amrita School of Medicine |
Approved |
| Ethics Committee-Biomedical and Health Research |
Approved |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee Dr Rela Institute and Medical Centre |
Approved |
| Institutional Ethics Committee Gleneagles Global Health City |
Approved |
| MAX Healthcare Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Sahyadri Hospitals PVT LTD Biomedical and Health Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C220||Liver cell carcinoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL as this is observational study |
NIL as this is observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
HCC downstaged with systemic therapy with or without locoregional therapy to within UCSF criteria |
|
| ExclusionCriteria |
| Details |
1. Extrahepatic metastasis
2. Poor performance status
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Overall survival at 1 year post transplant and end of study- Transplant Benefit (comparison between the 4 groups)
2. Recurrence free survival at 1 year post transplant and end of study (Group 1, 4)
3. Recurrence rate at 1 year post transplant and end of study (Group 1, 4)
|
3 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Rejection rate over 1 year (Group 1, 4)
2. Surgery related complications – bleeding, wound healing, biliary complications, infections (Group 1, 4)
3. Duration of stable disease before transplant – correlation with recurrence (Group 1, 4)
4. Tumour characteristics on explant histology – correlation with recurrence (Group 1, 4)
5. Pre Transplant Response to Systemic therapy – partial or complete - correlation with recurrence- Radiological & biochemical (Group 1, 4)
6. Recurrent disease – intrahepatic or extrahepatic (Group 1, 4) |
3 years |
|
Target Sample Size
Modification(s)
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study rationale- BCLC C hepatocellular carcinoma (HCC) downstaged with locoregional therapy (LRT) has acceptable 5 year post transplant survival. We propose to study the effect of systemic therapy with/without locoregional therapy for downstaging HCC and to see post transplant outcomes like overall survival, recurrence, surgical complications and rejection. Case series are available for the same where patients downstaged with systemic therapy have been successfully transplanted but there is no large prospective multicentric data. |