KCT0003631招募中未知
Phase II Study of PDR001 in Patients With Squamous Cell Carcinoma of the Esophagus
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 45
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 0No Limit（—）
- 性别
- All
入选标准
- •1. Histologically confirmed squamous cell carcinoma of the esophagus
- •2. Age = 20
- •3. ECOG PS(Eastern Cooperative Oncology Group performance) 0-2
- •4. Ineligibility for local therapy (surgery or radiotherapy)
- •5. Prior palliative chemotherapy including platinum-based chemotherapy. When recurred within 6 months of definitive/neoadjuvant/adjuvant chemo- or chemo-radiation, the chemotherapy is considered a line of therapy
- •6. At least one uni-dimensionally measurable disease as defined by irRECIST ver 1.1
- •7. Adequate organ function for treatment (Table 1)
- •8. 12-Lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
- •9. QTc interval =470 msec and without history of Torsades de Pointes or other symptomatic QTc abnormality
- •10. LVEF (by MUGA or echocardiogram) of =50%
- •11. The patient has provided signed informed consent
排除标准
- •1. Presence of symptomatic CNS metastases, or CNS metastases that require local CNSdirected therapy (such as radiotherapy or surgery). Patients with treated brain metastases should be neurologically stable (for 4 weeks post treatment and prior to study enrollment) and off of steroids for at least 2 weeks before administration of any study drug.
- •2. Previous treatment with anti- PD-1, PD-L1 or macrophage colony-stimulating factor antibody or inhibitor
- •3. Two or more previous systemic cytotoxic chemotherapy (chemotherapy administered with concurrent radiotherapy for local control is not counted)
- •4. Any major operation or irradiation within 4 weeks of baseline disease assessment
- •5. Any medical condition that would, in the investigator’s judgement, prevent the patient’s participation in the clinical study due to safety concerns, compliance with clincial study procedures or interpretation of study results, including but not limited to:
- •Prior immune-related adverse events requiring treatment discontinuation
- •Ongoing symptomatic interstitial lung disease (ILD), noninfectious pneumonitis or history of drug induced interstitial lung disease
- •6. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- •Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade = 2), uncontrolled hypertension or clinically significant arrhythmia
- •QTcF > 470 msec on screening ECG or congenital long QT syndrome
- •Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry
- •7. Active infection, including active tuberculosis requiring systemic antibiotic therapy
- •8. Known human immunodeficiency virus (HIV) infection (no testing required).
- •9. Active hepatitis B (HBV surface antigen [HBsAg] positive), active hepatitis C (HCV). However, patients who have previously had or have resolved HBV infection (hepatitis B central antibody [anti-HBc antibody] is present and no BHsAg) are eligible to participate in this trial. Patients positive for hepatitis C antibody may participate in the test only if the polymerase chain test for HCV RNA is negative.
- •10. Use of any live vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
- •11. Major surgery within 2 weeks of the first dose of study treatment (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
- •12. Radiotherapy within 2 weeks of the first dose of study drug, except for palliative radiotherapy to a limited field.
- •13. Systemic anti-cancer therapy within 2 weeks or 5 x T ½, whichever is longer of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks is indicated as washout period. For patients receiving CTLA-4, PD-1 or PD-L1 antagonists, 6 weeks is indicated as the washout period
- •14. Presence of = CTCAE Grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if = CTCAE Grade 3) due to prior cancer therapy
- •15. Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.
- •16. Pregnant or lactating women, where pregnancy is defined as the
研究者
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