KCT0004186已完成未知
An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination with Paclitaxel in Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric Cancer.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 62
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 o Limit（—）
- 性别
- All
入选标准
- •1. Has provided signed written informed consent
- •2. Has a histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma (systemic metastasis or locally advanced unresectable gastric cancer). A subject must have previously received 1st line chemotherapy using fluoropyrimidine and platinum, and showed progression)
- •3. Has documented EBV-related, MSI-high, or PD-L1 positive tumor in primary or metastatic tumor tissue (only confined to phase II study).
- •4. Has a life expectancy of at least 3 months
- •5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6. Has measurable or evaluable disease as determined by RECIST(Response Evaluation Criteria in Solid Tumors) Version 1.1.
- •7. Is able to swallow and retain orally administered medication
- •8. Has adequate baseline organ function
排除标准
- •1. Has HER2-positive or indeterminate gastric cancer
- •2. Have multiple cancers
- •3. Have a current or past history of severe hypersensitivity to any other antibody products
- •4. Have concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- •5. Have a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings
- •6. Have brain or meninx metastases.
- •7. Have pericardial fluid, pleural effusion, or ascites requiring treatment
- •8. Have a history of uncontrollable or significant cardiovascular disease meeting any of the following;
- •- myocardial infarction within 180 days before study enrolment
- •- uncontrollable angina pectoris within 180 days before study enrolment
- •- New York Heart Association (NYHA) Class III or IV congestive heart failure
- •- uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure =150 mmHg or diastolic blood pressure =90 mmHg lasting 24 hours or more) arrhythmia requiring treatment
- •9. Have systemic infection requiring treatment
- •10. Are contraindicated for paclitaxel
- •11. Has had prior treatment with:
- •- Require or, within 28 days before treatment, have received systemic corticosteroids (except for temporary use, e.g., for examination, prophylaxis of allergic reactions, or reduction of radiotherapy-related edema) or immunosuppressants
- •12. Have undergone surgery (any surgery involving general anesthesia) within 28 days before study treatment
- •13. Have received radiotherapy for gastric cancer within 28 days before treatment.
- •14. Have a positive test result for human immunodeficiency virus-1 (HIV-1) antibody,
- •15. has active B-viral hepatitis or C-viral hepatitis
- •16. Are pregnant or breastfeeding, or possibly pregnant
- •17. Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment.
- •18. Have previously received nivolumab, anti-programmed cell death-1 (PD-1) antibody, anti-PD-L1 antibody, anti-programmed cell death-ligand 2 (PD-L2) antibody, anti-CD137 antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells
- •19. Are incapable of providing consent for specific reasons, such as concurrent dementia
- •20. Are otherwise inappropriate for this study in the investigator’s or subinvestigator’s opinion.
研究者
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