CTRI/2020/10/028544 [Registered on: 22/10/2020] Trial Registered Prospectively
Last Modified On:
15/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Diagnostic
Study Design
Single Arm Study
Public Title of Study
A clinical study to evaluate the effect of cTACE with Lipiodol in treatment of HCC patients
Scientific Title of Study
Safety and Efficacy of Transarterial Chemoembolization with Lipiodol® in the treatment of inoperable Hepatocellular Carcinoma (HCC) in Indian Patients, Phase IV Clinical Trial
Siro Clintech Private Limited,
ASMACO house, Plot no B 41, Road no 27, Wagle industrial estate, Thane (W)-400604.
Landmark - near ITI
Thane MAHARASHTRA 400604 India
Phone
02261088000
Fax
02261088045
Email
somesh.bolegave@siroclinpharm.com
Source of Monetary or Material Support
GUERBET, B.P. 57400, 95943 Roissy CdG Cedex, France
Primary Sponsor
Name
GUERBET
Address
B.P. 57400, 95943 Roissy CdG Cedex, France
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Mr Piyush Shrawat
Guerbet India Liaison Office, 2015,
Corporate-Edge, Building No.5, Tower C, Level
20, DLF Cyber Terraces, Phase III, DLF Cyber
City, Gurgaon-122002, INDIA
All India Institute of Medical Sciences,
Department of Radiology Basni, II phase Jodhpur-342005
Jodhpur RAJASTHAN
8003996914
pushpinderkhera@gmail.com
Dr Shivanand Gamanagatti
All India Institute of Medical Science (AIIMS), New Delhi
Room Number 82B, Ground Floor, Department of Radio Diagnosis,All India Institute of Medical Science, Ansari Nagar (East), Gautam Nagar, New Delhi-110029, India New Delhi DELHI
919868398508
shiv223@gmail.com
Dr Kurunkar Sagar Ramesh
Apple Saraswati Multispeciality Hospital
Apple Saraswati Multispeciality Hospital, 805/2,804/2, Circuit house to Kadamwadi Road, Bhosale Wadi Kolhapur- 416003 Kolhapur MAHARASHTRA
912312688888
appleresearch88@gmail.com
Dr Jagadeesh R
Asian Institute of Gastroenterology
Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad - 500 082 Hyderabad TELANGANA
9989698341
rjsrads@gmail.com
Dr Srinivas M R
Bangalore Medical College and Research Institute, Victoria Hospital
Department of Radio-Diagnosis
Ground Floor, Department of Radiology Bangalore Medical College and Research Institute, Victoria Hospital, Fort, K.R. Road, Bengaluru-56002 Bangalore KARNATAKA
9844962444
sinumr25@gmail.com
Dr Ajitkumar Shivaji Patil
Dr Vasantrao Pawar Medical College, Nashik
Centre for Developmental & Translational Research, 4th Floor, Near MRD Section Dr Vasantrao Pawar Medical College, Nashik Nashik MAHARASHTRA
09860692498
drajitpatil4@yahoo.com.in
Dr Lenon Dsouza
Father Mulller Medical college Hospital
Father Mulller Medical college Hospital,Father Muller Road, Kankanady, Mangalore,
Karnataka, India- 575002 Dakshina Kannada KARNATAKA
9845969500
dsouza.lenon@gmail.com
Dr Rathod Jawahar Rajusingh
GMC and Hospital, Nagpur
GMC and Hospital, Department of Radio-Diagnosis, Trauma Care Centre, Government Medical College and Hospital, Nagpur Nagpur MAHARASHTRA
Department Of Medical Oncology Kasturba Medical College and Hospital, Manipal-576104 Udupi KARNATAKA
9880239139
dr.pai.ananth@gmail.com
Dr Navin Mallikarjun Mulimani
KLEs Dr. Prabhakar Kore Hospital and MRC, Belgaum
Department Of Interventional Radiology KLES Dr. Prabhakar Kore Hospital and MRC Belagavi 0590010 Belgaum KARNATAKA
08312470400
navinmulimani@gmail.com
Dr Vimal Someshwar
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Rao saheb Achutrao Patwardhan Marg Four Bunglows Andheri West Mumbai Mumbai City Maharashtra 400053 India Mumbai MAHARASHTRA
9820064685
vimal.someshwar@kokilabenhospitals.com
Dr Vivek Ukirde
Lokmanya Tilak Municipal General Hospital (LTMGH), Mumbai
OPD No 39, Room Number 2,4 & 5, Ground Floor, Department of Radiology (Vascular & Neuro Interventional), Lokmanya Tilak Municipal General Hospital, Dr. Babasaheb ambedkar Road RB2, Central Railway Quarters, Sion West, Mumbai, Maharashtra 400022 Mumbai MAHARASHTRA
919326079909
druvrays@gmail.com
Dr Pole Shivaji Marotrao
Mahatma Gandhi Mission’s Medical College & Hospital, Aurangabad
Radiology Department Mahatma Gandhi Mission’s Medical College & Hospital, Aurangabad-431003 Aurangabad MAHARASHTRA
9822333380
drsmp111@gmail.com
Dr Nandy Dipayan Jayanta
Parul Institute of Medical Sciences & Research, Limda
Department of Surgery,
Room Number 18 Parul Institute of Medical Sciences & Research, Limda, Ta.Waghodia, Vadodara 391760 Vadodara GUJARAT
9909012678
dipayannandy@gmail.com
Dr Naveen Kalra
Postgraduate Institute of Medical Education and Research (PGIMR)
Postgraduate Institute of Medical Education and Research (PGIMR), Department of Radiodiagnosis, Sector 12, Chandigarh-160012, India Chandigarh CHANDIGARH
9855426320
navkal2004@yahoo.com
Dr Rajanikant R Yadav
SGPGI, Lucknow
Block F, Old OPD, Ground Floor, Department of Radiodiagnosis, SGPGI, Raebareli Road, Lucknow, Uttar Pradesh-226014, India Lucknow UTTAR PRADESH
Lipiodol ® Ultrafluid (10 ml type I glass ampoule)
- Each cTACE procedure will be performed by administering an emulsion of Lipiodol® Ultra Fluid (IMP) mixed with chemotherapy followed by embolization with PVA particles or gelatin sponge particles according to routine practice of each site and investigator’s decision.
- The volume of emulsion of Lipiodol® Ultra Fluid and chemotherapy agent used for cTACE will be determined according to tumor size and extension of lesions.
- Lipiodol® Ultra Fluid: volume up to maximum 15 ml (in this case a second IMP will be allocated to the subject)
- In case of a second vascular embolization procedure for a single subject, a second IMP will be allocated to the subject;
- Chemotherapy agent: according to site practices and investigator decision.
- According to investigator decision, the respective volumes of Lipiodol® Ultra Fluid and chemotherapy agent could be in the ratio of 1:1, 2:1 or 3:1 but other ratio are accepted in respect of local practice.
1. Patient, male or female ≥18 years old, with a life expectancy of minimum 6 months
2. Patient having read the information and having provided her/his consent to participate
3. Patient with confirmed diagnosis of HCC as stated below
Cirrhotic patient: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria
Non-cirrhotic patient: histological confirmation is mandatory
4. Patient with HCC not suitable for curative therapies such as resection, liver transplantation or local ablative therapy (radiofrequency ablation or microwave ablation) or patient rejecting the above treatments
5. Patient with multi-nodular or single nodular tumor over 5 cm (in the case of single nodule less than 5cm, if curative treatment is contra-indicated or the patient rejects curative treatment)
6. Patient with at least one target lesion defined as an untreated uni-dimensional measurable lesion according to mRECIST by CT-scan or MRI examination
7. Patient with ECOG performance status of 0 or 1
8. Patient with Child-Pugh classification from A to B7 as acceptable maximum
9. Patient with proper blood, liver, renal and heart functions: testing results should be obtained within 14 days prior to cTACE:
a. white blood cell number > 3,000/mm3
b. platelet number ≥ 5 x 104/mm3
c. hemoglobin > 8.0 g/dL
d. serum total bilirubin ≤ 3.0 mg/dL
e. AST, ALT ≤ 5 times of upper limits of normal (ULN)
f. estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73m²
g. left ventricular ejection fraction (LVEF)≥50% as measured by 2-D echocardiogram
10. Patient who are willing to comply with visits/procedures required by protocol
ExclusionCriteria
Details
1. Patient with ECOG performance status ≥ 2,
2. Patient with Child-Pugh class B8 and above
3. Patient with diffuse HCC or presence of biliary invasion on previous CT/MRI examination available at screening or extra-hepatic spread
4. Patient with tumor burden involving more than 50% of the liver according to investigator judgement
5. Patient with macroscopic vascular invasion of the main portal vein (right, left or common trunk) or hepatic vein or vena cava detected by the CT or MRI examination
6. Patient with target lesions that have previously undergone local treatment, including resection, radiofrequency ablation (RFA) or microwave ablation (MWA), percutaneous ethanol injection (PEI) or cTACE/ trans-arterial embolization (TAE), prior treatments on non-target lesions are acceptable
7. Patients having received anthracyclines or radiotherapy or a kinase inhibitor or other systemic treatment for HCC
8. Patient with liver tumor rupture
9. Patient with history of biliary tract repair or endoscopic treatment of the biliary tract potentially compromising the treatment
10. Patient with clinically important refractory ascites or pleural effusion potentially compromising the treatment
11. Patient with any contraindications for hepatic embolization procedures
· Known hepatofugal blood flow
· Severe arterio-portal or arterio-venous shunts
· Impaired clotting test (platelet count < 5 x 104/mm3,
· Prothrombin Time- International Normalized Ratio (PT-INR) > 2.0)
Testing results should be obtained within 14 days prior to cTACE.
12. Patient with known contra-indication to the use or with known sensitivity to Lipiodol® Ultra Fluid, to its ingredients or to drugs from a similar pharmaceutical class, or with known contraindication(s) to the use or known hypersensitivity to chemotherapeutic agent
13. Patient currently treated with beta-blockers and/or metformin who cannot stop their treatment 2 days prior to cTACE
14. Patient treated with Interleukin II in the past 30 days
15. Patient with contrast media allergy contraindicating angiography
16. Pregnant or breast-feeding female patient, nursing or childbearing age female patient (a female patient of childbearing potential or with amenorrhea for less than 12 months must have a negative pregnancy test at trial entry) or male patient who are sexually active without medically acceptable contraception
17. Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct
18. Patient having received any investigational medicinal product within 30 days prior to trial entry
19. Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient’s safety or her/his ability to participate to the trial
20. Patient previously screened in this trial
21. Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the trial
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To assess the safety of cTACE in treatment of HCC
Entire Study period
Secondary Outcome
Outcome
TimePoints
1)The Safety profile of cTACE in the treatment of HCC based on the reporting of every TEAE occurring during the study period, according to
•the causal relationship of TEAEs with the Lipiodol® Ultra Fluid [IMP],
•the causal relationship of TEAEs with the chemotherapy / embolization agent [AMP],
•the causal relationship of TEAEs with the a study procedure
1) Entire Study Period
Target Sample Size
Total Sample Size="125" Sample Size from India="125" Final Enrollment numbers achieved (Total)= "125" Final Enrollment numbers achieved (India)="125"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, open, multicenter, single-arm phase IV Trial.
The trial is designed to investigate the safety and efficacy of Lipiodol during cTACE in inoperable HCC patients treated with cTACE. Patients will be enrolled prospectively when they are scheduled for a cTACE procedure which will include anticancer drugs (possibly doxorubicin, cisplatin,epirubicin or mitomycin or any combination of these drugs) according to each site clinical practice and at investigator’s decision. They will be followed for 6 months after the first cTACE excepted in case of premature withdrawal. During this period, the patients will be allowed to receive additional optional cTACE upon Investigator’s judgement.
The TEAEs will be assessed using NCI-CTCAE. Their causal relationship with Lipiodol®, chemotherapy and/or procedure will be assessed by the Investigator.
The local tumor response of the lesion(s) treated by initial cTACE procedure (performed at Visit V2) will be evaluated with MRI examinations according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Screening visit (V1) will be performed within 14 days prior to inclusion and cTACE procedure (V2). Follow-up visits post-V2 including imaging-based tumor response monitoring and safety evaluations will be performed at 6 weeks+/-14days (V3) and then at 3 months+/-14days (V4). The patients will be followed until 6 months+/-14days (V5) post-V2 for tumor response assessment and safety evaluation whatever the number of cTACE procedures.