CTRI/2020/10/028544招募中4 期
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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- GUERBET
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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