CTRI/2020/08/027136招募中4 期
A PROSPECTIVE, MULTICENTRE, POST-MARKETING PHASE IV STUDY TO ASSESS THE SAFETY AND EFFICACY OF LENVATINIB AS FIRST-LINE TREATMENT IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
Eisai Pharmaceuticals India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
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. Males or females of ââ?°Â¥ 18 years of age.
- •2. Patient or their legally acceptable representative (LAR) is willing to sign written informed consent for participation in the study and ready to comply with the study procedures and schedule.
- •3. Patient must have a confirmed diagnosis of unresectable hepatocellular carcinoma (HCC) with one of the following criteria:
- •a)Histologically or cytologically confirmed diagnosis of HCC.
- •b) Clinically confirmed diagnosis of HCC according to the American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any aetiology or with chronic hepatitis B or C infection criteria.
- •4. At least 1 measurable target lesion according to RECIST 1.1 meeting the following criteria:
- •a. Hepatic lesion:The lesion can be accurately measured in at least one dimension as ââ?°Â¥ 1.0 cm.
- •The lesion is suitable for repeat measurement.
- •b. Non-hepatic lesion: Lymph node (LN) lesion that measures at least one dimension as ââ?°Â¥ 1.5 cm in the short axis, except for porta hepatis LN that measures ââ?°Â¥ 2.0 cm in the short axis.Non-nodal lesion that measures ââ?°Â¥ 1.0 cm in the longest diameter.
- •c. Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
- •5. Patient is categorized to stage B (not applicable for TACE) or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system.
- •6. Patient has adequate bone marrow function, defined as:
- •a)Absolute neutrophil count (ANC) ââ?°Â¥ 1.5 Ã?â?? 109/L.
- •b) Haemoglobin ââ?°Â¥ 8.5 g/dL.
- •c)Platelet count ââ?°Â¥ 75 Ã?â?? 109/L.
- •7. Adequate liver function based on liver function tests, defined as:
- •a) Albumin ââ?°Â¥ 2.8 g/dL.
- •b) Bilirubin ââ?°Â¤ 3.0 mg/dL.
- •c) Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) ââ?°Â¤ 5 Ã?â?? the upper limit of normal (ULN).
- •8. Adequate blood coagulation function, defined as international normalized ratio (INR) ââ?°Â¤ 2.3.
- •9. Adequate renal function, defined as > 30 ml/min calculated as per the Cockcroft and Gault formula#.
- •10. Adequately controlled blood pressure (BP) with 0 or 1 antihypertensive medications, defined as BP ââ?°Â¤ 150/90 mm Hg at screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1.
- •11. Adequate pancreatic function, defined as amylase and lipase ââ?°Â¤ 1.5 Ã?â?? ULN.
- •12. Patient with a Child-Pugh score A.
- •13. Patient with Eastern Cooperative Oncology Group (ECOG) performance status of 0ââ?¬â??1.
- •14. Patient with life expectancy of ââ?°Â¥ 12 weeks from the start of study treatment, as per Investigatorââ?¬•s judgement.
排除标准
- •Patients who meet any of the following criteria will be excluded from this study.
- •1. Patients with imaging findings for HCC corresponding to any of the following:
- •a) HCC with ââ?°Â¥ 50% liver occupation.
- •b) Clear invasion into the bile duct.
- •c) Portal vein invasion at the main portal branch (Vp4).
- •2. Patients who have received any systemic chemotherapy, including sorafenib, or immunotherapy, or any systemic investigational anticancer agents for advanced/unresectable HCC.
- •Note: Patients who have received local hepatic injection chemotherapy are eligible.
- •3. Patients who have received any anticancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, e.g. granulocyte colony-stimulating factor [G-CSF]) within 28 days prior to enrolment.
- •4. Patients who have not recovered from toxicities as a result of prior anticancer therapy, except alopecia and infertility.
- •Recovery is defined as < Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
- •5. Patients with significant cardiovascular impairment including but not limited to the history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within previous 6 months, or cardiac arrhythmia requiring medical treatment at the time of screening.
- •6. Patients with prolongation of QTc interval to > 480 ms.
- •7. Patients with gastrointestinal malabsorption or any other condition that might affect the absorption of Lenvatinib in the opinion of the Investigator.
- •8. Bleeding or thrombotic disorders or use of anticoagulants such as, warfarin or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin is allowed).
- •9. Patients having a gastrointestinal bleeding event or active haemoptysis (bright red blood of at least 0.5 teaspoon) within 28 days prior to enrolment.
- •10. Patients with gastric or oesophageal varices that may require treatment.
- •11. Patients with any other active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months prior to enrolment.
- •12. Any history of, or concurrent, brain or subdural metastases.
- •13. Patients having > 1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Patients with urine protein ââ?°Â¥ 1 g/24 h will be excluded.
- •14. Patients with arterial-portal venous shunt or arterial-venous shunt preventing a proper diagnosis of the tumour.
- •15. Any medical or other condition that in the opinion of the Investigator would preclude the patientââ?¬•s participation in the study.
- •16. Patients with known intolerance to Lenvatinib (or any of the excipients).
- •17. Patients with positive human immunodeficiency virus (HIV) or active infection requiring treatment (except for hepatitis virus).
- •18. Patients who cannot be evaluated by either triphasic liver CT or triphasic liver MRI because of
研究者
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