KCT0008408尚未招募未知
Phase Ib/II Clinical Trial to Evaluate the efficacy and safety of Neo-adjuvant chemotherapy with Autologous Cytokine-Induced Killer Cells Therapy in patients with estrogen receptor negative/HER-2 negative breast cancer
ational Cancer Center0 个研究点目标入组 51 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
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
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1 A planned neoadjuvant therapy with AC and docetaxel in patients with histologically confirmed locally advanced breast cancer
- •2 Age ≥19 to ≤70 years
- •3 cT2N0 or cT1-3/N+ M0 (ER/PR negative [Allred score <3], c-erbB2 0, 1+ or 2+ [SISH negative])
- •4 Available biopsy sample (FFPE) at diagnosis. If tested at other hospitals, a slide for ER, PR, HER2, KI67 immunohistochemistry reading and 15 additional unstained slides are required.
- •5 HER2-negative breast cancer
- •6 At least 1 measurable lesion as per RECIST 1.1 on the image
- •7 Women of childbearing potential who agreed to use adequate contraception during the study (from the start to few hours or days after the last administration considering the half-life)
- •8 ECOG performance status of 0-2
- •9 Adequate organ function (Appendix A)
- •10 Voluntarily signed the written consent form to participate in the study
排除标准
- •1 Inflammatory breast cancer
- •2 Bilateral breast cancer
- •3 Clinical T4Nx
- •4 Stroke including transient ischemic attack
- •5 Untreated pulmonary thrombosis or deep vein thrombosis within 6 months: Patients are eligible if they had no symptoms after at least 6 weeks of therapeutic anticoagulant therapy within 6 months
- •6 Prior history of malignant tumor, with the exception of following:
- •6.1 Malignant tumor of a different type, with DFS of 3 years
- •6.2 Complete resection of skin tumor, except for melanoma
- •6.3 Curatively resected early gastric cancer
- •6.4 Differentiated thyroid cancer of <1 cm in size
- •7 Ejection fraction <55% on multi-gated acquisition scan (MUGA) scan/echocardiography (echoCG)
- •8 Clinically significant gastrointestinal malabsorption
- •- including, but not limited to:
- •8.1 Active peptic ulcer
- •8.2 Inflammatory bowel disease
- •8.3 Other gastrointestinal diseases at risk of perforation, history of gastrointestinal perforation, fistula or intraperitoneal abscess
- •9 Difficulty in administering anthracyclines due to arrhythmia or valvular heart disease as determined by the investigator
- •10 Clinically significant gastrointestinal malabsorption
- •- including, but not limited to:
- •10.1 Malabsorption syndrome
- •10.2 Major resection of the stomach or small bowel
- •11 Corrected QT interval >480 msec in electrocardiogram (ECG)
- •12 Following cardiovascular abnormalities in the last 6 months:
- •12.1 Coronary angioplasty or stenting
- •12.2 Acute myocardial infarction
- •12.3 Unstable angina
- •12.4 Coronary bypass grafting
- •12.5 Symptomatic peripheral artery diseases
- •13 Congestive heart failure of New York Heart Association (NYHA) class III or IV(Appendix B)
- •14 Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- •15 Major surgery or trauma within 28 days prior to the first study treatment and/or unhealed wound, fracture, ulcer: maneuver such as catheter placement is not included in the major surgery
- •16 Acute bleeding or bleeding tendency
- •17 Lesion in the airway or risk of pulmonary hemorrhage due to a lesion involving major pulmonary blood vessels (Patients with a tumor in contact with blood vessels but not invading them are eligible)
- •18 Protruding lesion in the main bronchus or lobar bronchi. Patients with a lesion in the segmental bronchus are eligible
- •19 Recent history of hemoptysis (within 8 weeks prior to the first study treatment, ½ teaspoons)
- •20 Administration of other non-tumor study treatment within 30 days prior to the first dose or 5 half-lives of the drug
- •21 Pregnant or breast-feeding women
- •22 A history of or current autoimmune diseases
- •23 Ineligibility or inability to participate in the study at the judgement of the investigator
研究者
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