A Phase II Single Arm, Multi-centre Study of Bevacizumab (Avastin®) Pre- and Post-transarterial Chemoembolisation (TACE) Treatment for Localized Unresectable Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Progression-free Survival
研究概览
简要总结
This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients, ≥ 18 years of age.
- •Liver cancer, not suitable for resection.
- •At least 1 measurable lesion, and overall tumor lesions occupying < 50% of liver volume
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
排除标准
- •Patients receiving concurrent radiotherapy or immunotherapy.
- •Patients who have received previous chemotherapy, biological agents, or radiotherapy.
- •Prior transarterial chemoembolisation (TACE) or transarterial embolisation (TAE).
- •Prior liver transplantation or liver resection.
- •Current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes.
- •Patients with high risk esophageal/gastric varices.
研究组 & 干预措施
Bevacizumab 5 mg/kg
Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
干预措施: Bevacizumab (Drug)
Bevacizumab 5 mg/kg
Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
干预措施: Transarterial chemoembolisation (TACE) (Procedure)
结局指标
主要结局
Progression-free Survival
时间窗: Baseline to the end of the study (up to 3 years, 3 months)
Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
次要结局
- Tumor Necrosis(Baseline to the end of the study (up to 3 years, 3 months))
- Time to Progression(Baseline to the end of the study (up to 3 years, 3 months))
- Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease(Baseline to the end of the study (up to 3 years, 3 months))
- Overall Survival(Baseline to the end of the study (up to 3 years, 3 months))
- Percentage of Participants With an Objective Response(Baseline to the end of the study (up to 3 years, 3 months))