A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus Sorafenib Versus Sorafenib for the Third-line Treatment of Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- progress-free survival,PFS
研究概览
简要总结
There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.
详细描述
Therapies targeting VEGF and mTOR signalling pathways represent standard first-line and second-line treatment options for patients with metastatic renal cell carcinoma. There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.To the best of the investigators knowledge, GOLD study is the first phase 3 trial in the third-line setting after both VEGF-inhibitor and mTOR-inhibitor drugs.From this study,Sorafenib may be option for the third-line treatment.The Best trial demonstrated that Bevacizumab/sorafenib had best efficacy in advance renal cancer canrcinoma and the VEGF/VEGFR co-inhibition strategy may warrant further investigation possibly with more selective VEGFR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years, ≤75 years, male or female
- •Advanced renal cellcarcinoma is diagnosed histologically or pathologically
- •1st line treatment of Sunitinib and 2nd line treatment of Everolimus and no more systemic anti-angiogenesis targeted drug therapy
- •Have at least one measurable tumor lesion (Response Evaluation Criteria In Solid Tumors)
- •Eastern Cooperative Oncology Group（ECOG) performance scale is 0 or 1
- •The expected life span is ≥12 weeks
- •No contraindications for chemotherapy, with enough liver function and renal function and normal ECG recording Peripheral hemogram: neutrophil≥1.5×109/L, Plt≥100×109/L, Hgb≥90g/L Renal function: serum creatinine≤1.5 folds the upper limit of normal (ULN) For patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 ULN, For patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 ULN
- •The patients participate voluntarily and have signed the informed consent form
排除标准
- •Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
- •Patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds
- •Past history of serious heart diseases, including: cardiac function classification ≥NYHA class II, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
- •Patients with a history of HIV infection or active phase of chronic hepatitis B/C
- •negative imaging examination result 4 weeks prior to enrollment)
- •Epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)
- •A history of allogeneic organ transplantation
- •Patients with evidence of hemorrhagic constitution or a past history of hemorrhage
- •Patients currently receiving renal dialysis
- •Past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment
- •Patients participating in other clinical trials simultaneously
- •Other conditions unsatisfying the inclusion criteria in the investigator's opinions
研究组 & 干预措施
Bevacizumab plus Sorafenib
Bevacizumab 5mg/kg Q2w Sorafenib 400mg Bid
干预措施: Bevacizumab (Drug)
Bevacizumab plus Sorafenib
Bevacizumab 5mg/kg Q2w Sorafenib 400mg Bid
干预措施: Sorafenib (Drug)
Sorafenib
Sorafenib 400mg Bid
干预措施: Sorafenib (Drug)
结局指标
主要结局
progress-free survival,PFS
时间窗: 2 years
Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 31 December 2017 cut of date
次要结局
- Safety: adverse events(1 years)
- overall survival,OS(3 years)
研究者
Jun Guo
Director of department of renal cancer and melanoma
Peking University Cancer Hospital & Institute