Phase II Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Plus Capatabine in Treating Patients With Metastatic Colorectal Cancer After Failure of Standard Treatment
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response rate(ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy.
详细描述
This is a Phase Ⅱ exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy.
All patients will receive recombinant anti-tumor and anti-virus protein for injection and capecitabine.
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
- •Aged above 18 years.
- •Pathologically confirmed metastatic adenocarcinoma of the colon or rectum. All other histological types are excluded.
- •Failure of Second-Line and more than second-line treatment, and fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens.(Subjects who progress during or within 3 months following the last administration of approved standard therapies and terminate standard treatment due to unacceptable toxicity warranting.).If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment.Subject received last-line treatment not including capecitabine.
- •At least one measurable lesion according to the RECIST criteria that has not been previously local treated. Minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral CT or NMR.Malignant lymph nodes short diameter as follows: greater than or equal to 15 mm measured by spiral CT.
- •ECOG performance status 0, 1 or
- •Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
- •Life expectancy of at least 3 months.
排除标准
- •Prior treatment with novaferon.
- •Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
- •Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
- •Patient who were allergic to Interferon-α or who had interferon-α antibody.
- •Patients with uncontrolled central nervous system (CNS) metastases.
研究组 & 干预措施
Novaferon+ xeloda
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.
干预措施: Novaferon (Drug)
Novaferon+ xeloda
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Overall response rate(ORR)
时间窗: every 6 weeks until disease progression,assessed up to 6 months
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
次要结局
- Disease control rate(DCR)(every 6 weeks until disease progression,assessed up to 6 months)
- Progression-free survival (PFS)(every 6 weeks until disease progression,assessed up to 6 months)
- Overall survival (OS)(every 8 weeks until death,assessed up to 2 years)
- Adverse Events(AEs)(from informed consent form signed to 30 days after termination of administration,assessed up to 6 months)