CTRI/2020/10/028544
Recruiting
Phase 4
Safety and Efficacy of Transarterial Chemoembolization with Lipiodol® in the treatment of inoperable Hepatocellular Carcinoma (HCC) in Indian Patients, Phase IV Clinical Trial - Not Applicable
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: C220- Liver cell carcinoma
- Sponsor
- GUERBET
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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