KCT0003334已完成未知
Phase II trial, multicenter, first line Paclitaxel-Avelumab Treatment for inoperable Angiosarcoma
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Signed written informed consent.
- •2.Male or female subjects aged = 20 years.
- •3.Histologically or cytologically proven metastatic or locally advanced Angiosarcoma.
- •4.Inoperable Angiosarcoma
- •5.Chemo-naïve patient
- •6.ECOG performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
- •7.Disease must be measurable with at least 1 measurable lesion by Response evaluation cirteria in solid tumor (RECIST) 1.1
- •8.Adequate hematological function defined by white blood cell (WBC) count = 3 × 109/L with absolute neutrophil count (ANC) = 1.5 × 109/L, lymphocyte count = 0.5 × 109/L, platelet count = 100 × 109/L, and hemoglobin = 9 g/dL (may have been transfused).
- •9.Adequate hepatic function defined by a total bilirubin level = 1.5 × the upper limit of normal range (ULN), an aspartate aminotransferase (AST), level = 2.5 × ULN, and an alanine aminotransferase (ALT) level = 2.5 × ULN or, for subjects with documented metastatic disease to the liver, AST and ALT levels
- •= 5 × ULN.
- •10.Adequate renal function defined by an estimated creatinine clearance > 30mL/min according to the Cockcroft-Gault formula.
- •Highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female subjects if the risk of conception exists
- •(Note: The effects of the study treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, defined in Appendix III or as stipulated in national or local guidelines. Highly effective contraception must be used 28 days prior to first study treatment administration, for the duration of study treatment, and at least for 60 days after stopping study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately.)
排除标准
- •1.Concurrent treatment with a non-permitted drug (see Section 14)
- •2.Prior therapy with any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody.
- •3.Concurrent anticancer treatment within 28 days before the start of trial treatment (e.g., cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin)
- •4.Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy)
- •5.Use of hormonal agents within 7 days before the start of trial treatment.
- •6.Use of any investigational drug within 28 days before the start of trial treatment.
- •7.Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of patients with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to = 10 mg prednisone daily). Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
- •8.Previous malignant disease other than the target malignancy to be investigated in this trial within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
- •9.Rapidly progressive disease (e.g., tumor lysis syndrome).
- •10.Active or history of central nervous system (CNS) metastases.
- •11.Receipt of any organ transplantation including allogeneic stem-cell transplantation.
- •12.Significant acute or chronic infections including, among others:
- •a.Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •b.Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive).
- •13.Active or history of any autoimmune disease (subjects with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.
- •14.Known severe hypersensitivity reactions to monoclonal antibodies (Grade = 3 NCI-CTCAE v4.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more features of partly controlled asthma).
- •15.Persisting toxicity related to prior therapy Grade > 1 NCI-CTCAE v4.0, however sensory neuropathy
- •= Grade 2 is acceptable.
- •16.Uncontrolled active infection
- •17.Genetic problems (ex. Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)
- •18.Pregnancy or breast feeding.
- •19.Known alcohol or drug abuse.
- •20.Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class = II), or serious uncontrolled cardiac arrhythmia requiring medication.
- •21.All other significant diseases (e.g., inflammatory bowel disease), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment.
- •22.Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- •23.Legal incapacity or limited legal capacity.
- •24.Vaccination within 4 weeks of the first dose of avelumab and while on study is prohibited except for adminis
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