NCT01695772已完成4 期
A Multi-Center, Single-Arm, Pilot Study of 5-FU Based Doublet Chemotherapy Plus Bevacizumab as Neoadjuvant Therapy for Patients With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Percentage of Participants Achieving Complete Resection (R0 Resection)
研究概览
简要总结
This open-label, single arm, multicenter study evaluated the resection rate in participants with colorectal cancer and previously untreated unresectable liver-only metastases after adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting. Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively, unless they experienced progressive disease or unacceptable toxicity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Chinese participants, 18-75 years of age
- •Histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed
- •Previously untreated unresectable liver-only metastases
- •Liver lesions determined to be unresectable by multidisciplinary team (MDT, consisting of experienced hepatic surgeons, medical oncologist and radiologist).
- •No previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, Transarterial chemoembolisation therapy (TACE) and target therapy
- •Adequate hematological, renal and hepatic function
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Life expectancy greater than (>) 3 months
排除标准
- •The relapse has occurred within 6 months of completion of the adjuvant treatment
- •Expected impossible to achieve complete resection (R0 resection) and/or gain 30% residual liver volume even with responsive neoadjuvant therapy
- •Participant cannot tolerate the surgery
- •Other malignancies in the past 5 years, except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- •Any extrahepatic metastases and/or recurrence of the primary tumor
- •Any residual toxicity from previous chemotherapy (except alopecia) of National Cancer Institute Common Toxicity Criteria (NCI CTC) v.4.0 grade 2
- •Hypertension crisis or encephalopathy
- •Pregnant or lactating women
- •Clinically significant cardiovascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Current or recent (within 10 days of study drug initiation) use of full dose of aspirin, clopidrogel or warfarin
- •History or evidence of Central Nervous System (CNS) disease (for example, primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
研究组 & 干预措施
Bevacizumab
Experimental
干预措施: 5-FU based doublet chemotherapy (Drug)
Bevacizumab
Experimental
干预措施: bevacizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Complete Resection (R0 Resection)
时间窗: At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)
R0 resection was defined as complete resection confirmed by pathology after pre-operative chemotherapy plus bevacizumab. Participants with R0 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.
次要结局
- Percentage of Participants Achieving Incomplete Tumor Resection (R1 Resection)(At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks))
- Percentage of Participants Achieving Objective Response(Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall))
- Number of Participants With Disease Progression or Relapse or Death(Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall))
- Progression Free Survival (PFS)(Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall))
- Percent Probability (PP) of Being Alive and Progression Free at Months 3, 6, 9, 12, 15, and 18(Months 3, 6, 9, 12, 15, and 18)
- Number of Participants With Disease Relapse or Death(Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall))
- Disease Free Survival (DFS)(Complete resection date up to disease relapse or death until data cutoff on 12 May 2016 (up to approximately 3.5 years))
- Percent Probability Of Being Alive and Disease Free at Months 3, 6, 9, and 12(Months 3, 6, 9, and 12)
研究者
研究点 (7)
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