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临床试验/NCT04049344
NCT04049344Unknown2 期

Phase II Multicenter Open-Label Single-Arm Study of Decitabine Combined With Oxaliplatin in Patients With Relapsed/Metastatic Renal Cell Carcinoma

Zhejiang Cancer Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
25
试验地点
1
主要终点
Progression free survival

研究概览

简要总结

The investigators reported previously that epigenetic activation of organic cation transporter (OCT2) by decitabine sensitizes RCC cells to oxaliplatin both in vitro and in xenografts. The objective of this phase II clinical trial is to investigate the efficacy and safety of sequential combination therapy with decitabine and oxaliplatin in patients with relapsed/metastatic renal cell carcinoma who progressed on standard of care.

详细描述

CHUCAS-025 (Cancer Hospital, University of Chinese Academy of Sciences) is a phase II trial conducted at 3 investigative centres in the Zhejiang Province, China. Eligible patients are 18 to 75 years old with relapsed/metastatic renal cell carcinoma progressed on standard of care. Patients receive Decitabine 10 mg/day for 5 consecutive days (d1-5) plus Oxaliplatin 75mg/m2 2-week-cycle (d6, d20) within 4 weeks. One cycle is defined as 4 weeks of treatment and total of 6 cycles are designed for patients. Patients who experienced unacceptable toxicities or clinical or documented progressive disease are discontinued from the study. The duration of any objective response is measured from the date the initial response is observed to the date that disease progression is observed. Patients receiving 2 cycles of treatment are considered evaluable for response using Response Evaluation Criteria in Solid Tumors (RECIST). Disease assessment by the investigator include response assessment and diagnostic imaging and measuring of target lesions. All patients receive computed tomography and/or magnetic resonance imaging scans for assessing disease status. All patients were followed up until death from any cause.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Combination of decitabine with oxaliplatin treatment

Experimental

Patients receive Decitabine 10 mg/day for 5 consecutive days (d1-5) plus Oxaliplatin 75mg/m2 2-week-cycle (d6, d20) within 4 weeks. One cycle is defined as 4 weeks of treatment and total of 6 cycles are designed for patients.

干预措施: Decitabine; Oxaliplatin (Drug)

结局指标

主要结局

Progression free survival

时间窗: Six months after randomization

Progression free survival is defined as the time from randomization to first documented RECIST-defined tumor progression or death from any cause. Disease assessments are performed with the use of computed tomography or magnetic resonance imaging at baseline, every 8 weeks for the first year, and then every 12 weeks until disease progression or discontinuation of treatment. Imaging data were evaluated by the investigator to assess tumor response (according to RECIST version).

次要结局

  • Overall survival(Two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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