Health Condition 1: C220- Liver cell carcinoma
Conditions
Interventions
Intervention1: 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
- 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 th
Sponsors
GUERBET
Mr Piyush Shrawat
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 · 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of cTACE in treatment of HCCTimepoint: Entire Study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 procedureTimepoint: 1) Entire Study Period | — |
Countries
India
Contacts
Public ContactDr Somesh Bolegave
Siro Clintech Private Limited
Outcome results
None listed