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CTRI Number  CTRI/2022/01/039380 [Registered on: 13/01/2022] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study on Management Outcomes in Patients With Unresectable Liver cell cancer 
Scientific Title of Study   A Multicountry, Multicentre, Noninterventional, Retrospective Study to Describe the Real-world Management Outcomes in Patients With Unresectable Hepatocellular Carcinoma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Akshay J K 
Designation  Study Physician 
Affiliation  AstraZeneca Pharma India Ltd  
Address  AstraZeneca Pharma India Ltd Manyatha Tech Park Bangalore

Bangalore
KARNATAKA
560045
India 
Phone    
Fax    
Email  akshay.javagal@astrazeneca.com  
 
Details of Contact Person
Public Query  
Name  Amit Kumar 
Designation  Project Delivery Lead 
Affiliation  AstraZeneca Pharma India Ltd  
Address  AstraZeneca Pharma India Ltd Manyatha Tech Park Bangalore

Bangalore
KARNATAKA
560045
India 
Phone    
Fax    
Email  amit.kumarAK@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca Pharma India Limited 
 
Primary Sponsor  
Name  AstraZeneca Pharma India Limited 
Address  Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Brazil
Egypt
Hong Kong
India
Republic of Korea
Saudi Arabia
Singapore
Taiwan
United Arab Emirates  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Praveen Kumar Bansal  Asian Institute of Medical Sciences  Badkal Flyover, Road, Sector 21A, Faridabad, Haryana 121001
Faridabad
HARYANA 		 9650099244

drpraveenkb@yahoo.com 
Dr Chandragouda Dodagoudar  BLK Hospital  Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi 110005
New Delhi
DELHI 		 9958450124

drchandru1976@yahoo.co.in 
Dr Chandrakanth M V  Narayana Superspeciality Hospital  Department of Medical Oncology, 120, 1, Andul Rd, near Nabanna, Shibpur, Howrah
Haora
WEST BENGAL 		 7738519198

drmvch@gmail.com 
Dr Vivek Agarwala  NH Rabindranath Tagore Institute of Cardiac Sciences  Department of Medical Oncology and Hemato-oncology, Premises No: 1489, Mukundapur Main Road, 124, Eastern Metropolitan Bypass, Mukundapur, Kolkata
Kolkata
WEST BENGAL 		 8879222875

drvivekagarwala@gmail.com 
Dr Vineet Talwar  RGCI  Sir Chotu Ram Marg, Sector – 5, Rohini Institutional Area, Rohini, New Delhi, Delhi – 110085
New Delhi
DELHI 		 9810241512

talvar.vineet@rgcirc.org 
Dr Somnath Roy  Tata Medical Center (TMC)  Department of Medical Oncology, 14 MAR (E-W), New Town, Rajarhat, Kolkata
Kolkata
WEST BENGAL 		 9051732283

sroysskm1980@gmail.com 
Dr Vikas Ostwal  Tata Memorial Hospital  Department of Medical Oncology, Dr. E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA 		 9930063599

dr.vikas.ostwal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Institutional Ethics Committee Asian Institute of Medical Sciences  Approved 
Institutional Ethics Committee Dr. B.L. Kapur Memorial Hospital  Approved 
Institutional Ethics Committee Rajiv Gandhi Cancer Institute and Research Centre  Approved 
Institutional Ethics Committee Tata Medical Center   Approved 
Institutional Ethics Committee Tata Memorial Hospital  Approved 
Narayana Superspeciality Hospital Ethics Committee  Approved 
NH Rabindranath Tagore International Institute of Cardiac Sciences Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C220||Liver cell carcinoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adult female or male patients aged ≥18 years or ‘adults’ according to the age of majority as defined by the local regulations at index diagnosis
2. Patients or legal representative (unless a waiver is granted) willing and be able to provide informed consent according to local regulations. For deceased patients at study entry, informed consent is not mandatory.
3. Patients with radiologically or histopathologically confirmed diagnosis (at index date) of unresectable BCLC stage B HCC, not considered eligible for initial loco-regional therapya or stage C advanced or metastatic disease between 01 January 2017 and 31 December 2019.
4. Availability of at least 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis. 
 
ExclusionCriteria 
Details  1. Patients with BCLC stage D HCC at index diagnosis
2. Patients with concomitant cancer, at the time of diagnosis of unresectable HCC, except for the nonmetastatic nonmelanoma skin cancers or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HCC diagnosis. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To describe the OS rate in patients with unresectable HCC including estimates of survival rates at 6, 12, and 18 months and at 2 years  One Year 
 
Secondary Outcome  
Outcome  TimePoints 
To describe the management patterns in patients with unresectable HCC
To describe the demographic and clinical characteristics of patients with unresectable HCC 		 One Year 
 
Target Sample Size   Total Sample Size="1250"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "1116"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/01/2022 
Date of Study Completion (India) 11/03/2024 
Date of First Enrollment (Global)  17/01/2022 
Date of Study Completion (Global) 11/03/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Patients with unresectable HCC are an extremely heterogeneous population, with several coexisting risk factors like underlying hepatic dysfunction, extrahepatic metastases, and macrovascular invasion (MVI) posing a challenge for optimum sequencing of the existing, newly approved, and emerging targeted therapies. Real-world studies have identified factors such as performance status, Child-Pugh class, MVI or extrahepatic metastasis and AFP levels, which predict the response to treatment.
Considering the treatment landscape with its dynamic algorithms and new approaches of sequencing, it is important to identify patient management patterns and survival outcomes arising from the current standard of care. Based on all these considerations, this multicountry, multicentre, noninterventional, real-world, retrospective study is designed to describe the management patterns, clinical characteristics, possible predictors, and survival outcomes in patients with unresectable HCC. The results of this study might help oncologists in optimal patient selection and sequencing of the systemic therapies.
 
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