Safety and Efficacy of Transarterial Chemoembolization with Lipiodol® in the treatment of inoperable Hepatocellular Carcinoma (HCC) in Indian Patients, Phase IV Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- GUERBET
- 入组人数
- 125
- 试验地点
- 21
- 主要终点
- To assess the safety of cTACE in treatment of HCC
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient, male or female ≥18 years old, with a life expectancy of minimum 6 months
- •Patient having read the information and having provided her/his consent to participate
- •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
- •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
- •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)
- •Patient with at least one target lesion defined as an untreated uni-dimensional measurable lesion according to mRECIST by CT-scan or MRI examination
- •Patient with ECOG performance status of 0 or 1
- •Patient with Child-Pugh classification from A to B7 as acceptable maximum
- •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.
- •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
- •Patient who are willing to comply with visits/procedures required by protocol.
排除标准
- •Patient with ECOG performance status ≥ 2,
- •Patient with Child-Pugh class B8 and above
- •Patient with diffuse HCC or presence of biliary invasion on previous CT/MRI examination available at screening or extra-hepatic spread
- •Patient with tumor burden involving more than 50% of the liver according to investigator judgement
- •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
- •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
- •Patients having received anthracyclines or radiotherapy or a kinase inhibitor or other systemic treatment for HCC
- •Patient with liver tumor rupture
- •Patient with history of biliary tract repair or endoscopic treatment of the biliary tract potentially compromising the treatment
- •Patient with clinically important refractory ascites or pleural effusion potentially compromising the treatment
- •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.
- •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
- •Patient currently treated with beta-blockers and/or metformin who cannot stop their treatment 2 days prior to cTACE
- •Patient treated with Interleukin II in the past 30 days
- •Patient with contrast media allergy contraindicating angiography
- •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
- •Patient having received any investigational medicinal product within 30 days prior to trial entry
- •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
- •Patient previously screened in this trial
- •Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the trial.
结局指标
主要结局
To assess the safety of cTACE in treatment of HCC
时间窗: Entire Study period
次要结局
- 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],)