FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/061668 [Registered on: 19/01/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Clinical trial/study Of Atezolizumab With Lenvatinib Or Sorafenib Versus Lenvatinib Or Sorafenib Alone In patients with Hepatocellular Carcinoma. 
Scientific Title of Study   A Phase III, Open-Label, Randomized Study Of Atezolizumab With Lenvatinib Or Sorafenib Versus Lenvatinib Or Sorafenib Alone In Hepatocellular Carcinoma Previously Treated With Atezolizumab And Bevacizumab. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MO42541_Version 3 dated 21Jul2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Vikas Ostwal 
Designation  Professor Medical Oncologist 
Affiliation  Tata Memorial Hospital  
Address  Room number 1102, Department of GI Medical Oncology, 11th floor, Homi Bhabha Block, Dr Ernest Borges Road Parel 400012, India. Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  9702288801  
Fax    
Email  dr.vikas.ostwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Viraj Suvarna 
Designation  Medical Chapter Lead and Chief Scientific Officer (ad interim) 
Affiliation  Roche Products (India) Pvt. Ltd. 
Address  Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall

Mumbai
MAHARASHTRA
400086
India 
Phone  9820006317   
Fax    
Email  viraj.suvarna@roche.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr Amol Pawar  
Designation  Manager -Clinical Operations  
Affiliation  Roche Products India Private Limited 
Address  Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall

Mumbai
MAHARASHTRA
400086
India 
Phone  8080780992  
Fax    
Email  amol.pawar@roche.com  
 
Source of Monetary or Material Support  
F. HoffmannLa Roche Ltd CH-4070 Basel, Switzerland 
 
Primary Sponsor  
Name  F HoffmannLa Roche Ltd  
Address  Grenzacherstrasse 124, CH-4070 Basel, Switzerland  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Roche Products India Pvt Ltd  146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai 
 
Countries of Recruitment     Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Costa Rica
Croatia
Egypt
Estonia
Finland
France
Germany
Greece
India
Israel
Italy
Japan
Malaysia
Philippines
Republic of Korea
Russian Federation
Saudi Arabia
Slovenia
Spain
Switzerland
Taiwan
Thailand
Turkey
United Kingdom  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Kulkarni  Asian Institute of Gastroenterology  No 136 Plot No 2,3,4,5 Survey 1 1st floor Cluster M Room no 2 Mindspace Road Gachibowli Hyderabad Telangana 500032
Hyderabad
TELANGANA 		 8553322434

anandvk90@gmail.com 
Dr Shekar Patil  HealthCare Global Enterprises Limited  5th floor, HCG Tower4, #8, P. Kalinga Rao Road, Sampangiramnagar 560027, India
Bangalore
KARNATAKA 		 9341245961

sp_associates6@rediffmail.com 
Dr Gaurav Prakash  Post Graduate Institute of Medical Education & Research  Dept. of Clinical hematology & Medical Oncology, Sector 12, 160012 Chandigarh, Punjab, India
Chandigarh
CHANDIGARH 		 8553322434

drgp04@gmail.com 
Dr Vikas Ostwal  Tata Memorial Hospital  Room number 1102, Department of GI Medical Oncology, 11th floor, Homi Bhabha Block, Dr Ernest Borges Road Parel 400012, India.
Mumbai
MAHARASHTRA 		 9702288801

dr.vikas.ostwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
HCG Central Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics committee I & II , TATA Memorial Hospital, Mumbai  Approved 
Intuitional Ethics Committee- Asian Institute of Gastroenterology (IEC-AIG)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C220||Liver cell carcinoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Atezolizumab  V infusion at a fixed dose of 1200 mg on Day 1 of each 21‑day cycle 
Comparator Agent  Lenvatinib  once a day by mouth (PO) during each 21-day cycle. 
Comparator Agent  Sorafenib  Dose of 400 mg (two 200 mg tablets) twice a day PO each day of every 21-day study treatment cycle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Locally advanced or metastatic and or unresectable HCC with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients.
Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease, partial response, or complete response.
Child-Pugh class A within 7 days prior to randomization.
ECOG Performance Status of 0 or 1 within 7 days prior to randomization.
Life expectancy of at least 12 weeks.
Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade less than equal to 1 prior to study entry, with the exception of alopecia.
 
 
ExclusionCriteria 
Details  Symptomatic, untreated, or actively progressing central nervous system metastases.
History of leptomeningeal disease.
History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days.
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
Patients receiving any TKI or PD-1/PD-L1 antibody or such combination in a previous treatment line against HCC (except atezolizumab plus bevacizumab combination).
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyteassociated protein 4 (CTLA-4), anti-PD-1, and anti-PD-L1 (other than atezolizumab) therapeutic antibodies.
Patients who discontinued atezolizumab in a previous treatment line against HCC primarily for toxicity or intolerability are not eligible for the study.
Patients on a liver transplantation list.
Prior allogeneic stem cell or solid organ transplantation. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared with lenvatinib or sorafenib alone  Tumor assessments will be performed at baseline, every 6 weeks (+1 week) for the first 54 weeks following the initiation of study
treatment, and every 9 weeks (+ 1 week) thereafter, with additional scans as clinically indicated. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared to lenvatinib or sorafenib alone  Assessments per investigator according to RECIST v1.1
-Progression free survival
-Confirmed objective response rate
-Time to progression
-Duration of response
-Time to deterioration of health-related quality of life  
To evaluate patient-reported function and GHS/QoL experienced by patients receiving atezolizumab plus lenvatinib or sorafenib versus lenvatinib or sorafenib alone  TTD, of HRQoL, defined as the time from randomization to first deterioration (decrease from baseline of more than equal to 10 points) maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks (if Cycle 1-6) or 6 weeks (if after Cycle 6) in the following EORTC QLQ-C30 scales (separately): physical function, role function, and GHS/QoL 
 
Target Sample Size
Modification(s)  		 Total Sample Size="554"
Sample Size from India="12" 
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 3 
Date of First Enrollment (India)   31/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/04/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in patients with locally advanced or metastatic HCC who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. Prior to each site initiation, either lenvatinib or sorafenib will be selected for study treatment by the investigator for all patients from the respective site. 
Close