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CTRI Number  CTRI/2025/03/081898 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comprehensive Genomic Profiling of Hepatocellular Carcinoma 
Scientific Title of Study   Comprehensive Genomic Profiling of Hepatocellular Carcinoma Assessing Genetic Alterations and Tumor Evolution Following Immunotherapy in Biopsy-Proven Patients PROGEN HCC study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonal Asthana 
Designation  Clinical Lead, HPB and Multiorgan Transplant Surgery 
Affiliation  Aster CMI Hospital 
Address  Aster CMI Hospital, Integrated Liver Care, Ground Floor, Room No:5,New Airport Road, NH.7, Sahakara Nagar Bengaluru, Karnataka

Bangalore
KARNATAKA
560092
India 
Phone  9686976379  
Fax    
Email  drsonal.asthana@asterhospital.in  
 
Details of Contact Person
Scientific Query  
Name  Akhil Deshmukh 
Designation  Consultant Hepatologist and Liver Transplant Physician 
Affiliation  Aster Whitefield Hospital 
Address  Aster Whitefield Hospital, Integrated Liver Care Plot No. 3 and 4, Sadaramangala Industrial Area, off Whitefield Main Road, opposite ITPL, Whitefield, Bengaluru, Karnataka

Bangalore
KARNATAKA
560066
India 
Phone  8078120847  
Fax    
Email  akhildeshmukh53@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akhil Deshmukh 
Designation  Consultant Hepatologist and Liver Transplant Physician 
Affiliation  Aster Whitefield Hospital 
Address  Aster Whitefield Hospital, Integrated Liver Care Plot No. 3 and 4, Sadaramangala Industrial Area, off Whitefield Main Road, opposite ITPL, Whitefield, Bengaluru, Karnataka

Bangalore
KARNATAKA
560066
India 
Phone  8078120847  
Fax    
Email  akhildeshmukh53@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Aster CMI Hospital 
Address  43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonal Asthana  Aster CMI Hospital  43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA 		 9686976379

drsonal.asthana@asterhospital.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aster CMI Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not Applicable  Not Applicable 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1 Adults greater than or equal to 18 years diagnosed with biopsy proven advanced or unresectable HCC.
2 Patients with BCLC stage C or BCLC stage B
3 Treatment naïve for systemic therapy.
4 Child Pugh A or B, ECOG lesser than or equal to 2
5 Signed informed consent.
 
 
ExclusionCriteria 
Details  1 Prior liver transplant.
2 Previous systemic therapy for HCC.
3 Significant comorbidities or active infections
4 High risk esophageal or gastric varices 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess genomic alterations in biopsy-proven hepatocellular carcinoma (HCC) patients at baseline and after 3 doses of immunotherapy with Atezolizumab and Bevacizumab.

 		 Baseline and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate the relationship between key genomic alterations e.g., CTNNB1, TERT, TP53 & immune phenotypes hot vs. cold following immunotherapy.
•To explore the association between genomic changes & clinical response, including tumour mutation burden TMB & immune cell infiltration.
 		 Baseline & 12 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   17/03/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patients with BCLC stage C or stage B hepatocellular carcinoma (HCC),will be recruited for the study. Informed consent will be obtained following a detailed explanation of the study, and baseline clinical data will be recorded.

Blood samples will be collected from each patient, with three tubes of 10 ml each. One BD K2 EDTA tube will be used for the analysis of circulating tumor cells (CTCs), while two PAXGENE® tubes will be used for circulating tumor DNA (ctDNA) analysis. These samples will provide important insights into the genetic changes in tumors without the need for invasive procedures.

The OncoDiscover® Liquid Biopsy test will be used to detect CTCs, which are indicative of cancer progression. Meanwhile, Oncolndx® NGS profiling will offer a comprehensive genomic analysis, covering over 1000 genes, including key actionable mutations, resistance markers, homologous recombination deficiency (HRD) scores, and immunotherapy markers such as tumor mutational burden (TMB) and microsatellite instability (MSI).

Blood samples will be transported to OneCell Diagnostics, Pune, for CTC enumeration and ctDNA testing using the OncoRADAR assay. This assay allows for the isolation and profiling of single CTCs, providing detailed insights into tumor heterogeneity and metastatic potential.

The genomic data generated from liquid biopsies, alongside traditional tissue biopsies, will be analyzed to assess their correlation with treatment response, disease progression, and clinical outcomes. This dual approach will provide a comprehensive understanding of how immunotherapy influences HCC at both the cellular and molecular levels.

 
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