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CTRI Number  CTRI/2025/04/084493 [Registered on: 09/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Radiation Therapy 
Study Design  Single Arm Study 
Public Title of Study   A combination of targeted radiation therapy (SBRT) and immunotherapy (atezolizumab-bevacizumab) for treating liver cancer that cannot be removed by surgery. 
Scientific Title of Study   Phase II, single arm prospective multicentre interventional study of SBRT (Stereotactic body radiotherapy) and Atezolizumab with Bevacizumab in 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  Dr Anant Ramaswamy 
Designation  Professor and Medical Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room no 1102 Department of medical oncology Homibhabha Building Tata Memorial Hospital Dr Ernest Borges Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9833034802  
Fax    
Email  anantr13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anant Ramaswamy 
Designation  Professor and Medical Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room no 1102 Department of Medical oncology Homibhabha Building Tata Memorial Hospital Dr Ernest Borges Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9833034802  
Fax    
Email  anantr13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anant Ramaswamy 
Designation  Professor and Medical Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room no 1102 Department of Medical oncology Homibhabha Building Tata Memorial Hospital Dr Ernest Borges Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9833034802  
Fax    
Email  anantr13@gmail.com  
 
Source of Monetary or Material Support  
Roche Pharmaceutical for Drug Support 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr Ernest Borges Road Parel Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
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 Anant Ramaswamy  Tata Memorial Hospital  Room no 1102 Department of Medical oncology Homibhabha Building Tata Memorial Hospital Dr Ernest Borges Parel Mumbai
Mumbai
MAHARASHTRA 		 09833034802

anantr13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II  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 
Intervention  Atezolizumab and Bevacizumab and SBRT  Patients enrolled in the study will receive a combination of Atezolizumab plus Bevacizumab and SBRT sequentially as follows 1. SBRT followed by Atezolizumab and Bevacizumab once every 3 weeks for a duration of 6 months (=9 cycles) If the patient continues to have disease stabilization or response at the completion of six months of therapy with atezolizumabbevacizumab and SBRT, the following treatment options will be considered 1. Observation 2. Continue atezolizumab-bevacizumab if feasible Both options will be considered acceptable Atezolizumab 1200 mg IV on day 1 repeated q 21days Bevacizumab 15mg per kg IV on day 1 repeated q 21 days 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  General Inclusion criteria Major
Age more than equal to 18 years at the time of signing informed consent document.
ECOG performance status 0 to 2
Child-Pugh Score less than equal to B7 within one week of study enrolment
Patients with both MPVT Vp3 or Vp4 and Child-Pugh Score B7 concurrently will not enroll in study
Barcelona Clinic Liver Cancer BCLC stages Intermediate B or Advanced C within 7 days of study registration.
Adequate end organ function
Inclusion criteria for Hepatitis B & Hepatitis C
Documented virology status of hepatitis B virus HBV as confirmed by screening HBV serology test within 28 days prior to study registration.
For participants with evidence of chronic HBV infection the HBV viral load must be undetectable on suppressive therapy if indicated.
For participants with active HBV HBV DNA less than 500 IU per mL obtained within 28 days prior to initiation of study treatment and AntiHBV treatment per local standard of care eg entecavir for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study.
Documented virology status of hepatitis C virus HCV as confirmed by screening HCV serology test within 28 days prior to study registration.
Inclusion criteria HCC related Major
Participants must have diagnosis of hepatocellular carcinoma HCC that is deemed unresectable, not a candidate for surgery RFA or further TACE. Histologically or cytologically proven diagnosis of HCC
At least 1 solid liver lesion more than 1 cm with arterial enhancement and delayed washout on multiphasic CT or MRI.
Maximum 5 lesions allowing minimum 700 cc of the spared liver volume Enhancing vascular thrombosis demonstrating arterial enhancement and delayed washout of multiphasic MRI. Macrovascular invasion VP4 is allowed. Radiologic imaging evaluation must occur within 30 days prior to study registration.
Participants must have measurable disease
Small volume extrahepatic disease permitted defined as less than 2 cm in sum of maximal diameters is allowable only for the presence of regional lymph nodes. Participants may have received transarterial chemoembolization TACE or DEB-TACE but at least 4 weeks prior to enrolment and not more than 3 sessions of TACE in last 6 months 
 
ExclusionCriteria 
Details  Patients with CTPB7 and VP4or VP3 status together ie if patients have VP3 or Vp4 status they will not be included if they have CTPB7 status. Conversely, if patient has CTPB7 status, they will not be included if they have VP3 or VP4 status. Prior systemic therapy, including tyrosine kinase inhibitors or immunotherapy Prior radiotherapy Prior selective internal radiotherapy SIRT or hepatic arterial Yttrium therapy, at any time. Direct tumor extension into the stomach, duodenum, small bowel or large bowel. Extrahepatic metastases unless as specified previously for locoregional lymph nodes Known fibrolamellar HCC, sarcomatoid HCC or biphenotypic 8 HCC. History of leptomeningeal disease. Active or history of autoimmune disease or immune deficiency Any specific contraindications to receive immune-checkpoint inhibitors Uncontrolled comorbidities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Overall Response rate ORR as per modified RECIST mRECIST. ORR will be a sum of
complete response CR and partial response PR rates 		 Accrual of 24 months plus 12 onth 
 
Secondary Outcome  
Outcome  TimePoints 
Progression free survival PFS at 12 months
Overall Survival OS at 12 months
Local control rates
Treatment related toxicity
Duration of response
 		 Accrual of 24 months plus 12 month 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   Phase 2 
Date of First Enrollment (India)   28/04/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The current single arm phase II study aims to explore the combination of atezolizumabbevacizumab with SBRT in patients with advanced and unresectable Hepatocellular carcinoma HCC. The primary aim of the study will be to evaluate whether the combination will improve overall response rates ORR in comparison to historical controls.  
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