NCT06034977招募中2 期
Genotype Selected, Randomized, Open Label, Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
To compare the clinical outcomes of Lenvatinib treatment alone or Lenvatinib + ADI-PEG20 combination treatment in advanced HCC patients with BCLC stage C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of HCC confirmed by radiology, histology, or cytology.
- •Patients were rs-6025211 non-TT with rs9679162 non-GG genotype , or serum arginine level ≥ 84.2 µM with rs9679162 non-GG genotype. Treatment naïve or under Lenvatinib treatment for < 2 months.
- •Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present.
- •Child-Pugh (cirrhosis status) score class A (Appendix C).
- •Barcelona Cancer of the Liver (BCLC) stage C (Appendix B).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment (Appendix D).
- •Expected survival of at least 3 months.
- •Age >18 years.
- •Fully recovered from prior surgery and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed.
- •Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Male partners of female subjects and female partners of male subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study if they are of childbearing potential. Females of childbearing potential must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this subject is deemed eligible. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual period for at least 12 months).
- •Informed consent must be obtained prior to study initiation.
- •No concurrent investigational studies are allowed.
- •Total bilirubin < 2.5 mg/dL and no evidence of bile obstruction.
- •Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x upper limit of normal range.
- •Serum albumin level ≥ 3.0 g/dl.
- •Prothrombin time (PT)-international normalized ratio (INR): PT <3 seconds above control or INR <1.
- •Absolute neutrophil count (ANC) >1,500/µL.
- •Platelets >50,000/µL.
- •Serum uric acid ≤ 8 mg/dL (with or without medication control).
- •Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL/min.
- •Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon.
- •Encephalopathy - none or mild (grade 1 or 2, by Child-Pugh classification); lactulose of other supportive care allowed.
- •Ascites - absent or slight (by Child-Pugh classification); diuretic therapy allowed.
排除标准
- •Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling of such drugs.
- •Prior allograft transplantation including liver transplantation.
- •Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies, except for Grade 1 alopecia.
- •Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
- •Pregnancy or lactation.
- •Expected non-compliance.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
- •Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.
- •Subjects who had been treated with ADI-PEG 20 previously.
- •History of uncontrolled seizure disorder not related to underlying cancer.
- •Known HIV positivity, or active hepatitis B infection, or active hepatitis C infection (AST or ALT > 5 x upper limit of normal).
- •Allergy to pegylated compounds.
- •Allergy to E. coli drug products (such as GMCSF).
- •Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.
- •Uncontrolled ascites (defined as not easily controlled with diuretic treatment).
- •Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until week 1 visit.
- •Use of traditional medicines approved by local authorities, including but not limited to Chinese herbs within 2 weeks prior to week 1 visit.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
研究组 & 干预措施
Lenvatinib
Placebo Comparator
Advanced HCC patients treated by Lenvatinib.
干预措施: ADI-PEG20 (Drug)
Lenvatinib + ADI-PEG20
Experimental
Advanced HCC patients treated by Lenvatinib + ADI-PEG20.
干预措施: ADI-PEG20 (Drug)
结局指标
主要结局
Overall survival
时间窗: 2 years after the last enrollment
Overall survival after the start of the intervention
次要结局
未报告次要终点
研究者
Wei-Ting Chen
Director, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCCHepatocellular CarcinomaNCT06519721RenJi Hospital15
撤回
2 期
Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma With Hepatitis B Virus InfectionHepatocellular CarcinomaNCT04044651Shi Ming
已完成
1 期
Lenvatinib and Eribulin in Advanced Soft Tissue SarcomaSoft Tissue Sarcoma AdultAdvanced CancerLeiomyosarcomaLiposarcomaNCT03526679National Taiwan University Hospital30
招募中
2 期
Lenvatinib Combined With PD-1 Inhibitors as First-line Treatment for Unresectable/Advanced Biliary Tract CarcinomaBiliary Tract CancerNCT05509478The First Hospital of Jilin University46
已完成
1 期
An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Selected Solid TumorsSolid TumorsJPRN-jRCT2080223435Eisai Co., Ltd.6