NCT04880811Unknown2 期
Phase 2 Study of Afatinib Plus Toripalimab in Previously Treated Recurrent or Metastasic Esophageal Squamous Cell Carcinoma With EGFR Overexpression or EGFR Amplification
Peking University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a phase 2 trial investigating the effect and safety of afatinib plus toripalimab in previously treated recurrent or metastasic esophageal squamous cell carcinoma with EGFR overexpression or EGFR amplification.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed informed consent.
- •Age 18 to 70 years old.
- •Histologically confirmed esophageal squamous carcinoma
- •Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.
- •Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.
- •Refractory or intolerant to at least one regimen.
- •Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment)
- •Life expectancy of ≥3 month
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level < 1.5 times ULN，Serum creatinine <1.5 times ULN，ALT and AST<2.5 times ULN ，AKP < 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
- •No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃.
- •Good compliance
排除标准
- •Currently receiving other effective regimens.
- •Previous anticipate other clinical trial within 4 weeks before entering this study.
- •No measurable lesions, eg. pleural fluid and ascites.
- •With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.
- •Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.
- •Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis.
- •HIV infection, active hepatitis B or hepatitis C.
- •Unstable systemic diseases such as poorly controlled diabetes.
- •Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT.
- •Keratitis, ulcerative keratitis or severe dry eye syndrome. Known hypersensitivity to study drug.
- •Pregnancy or lactation period.
- •Active severe infection within 14 days
- •Contraindications of afatinib.
- •Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding
- •Gastrointestinal perforation and/or fistula occurred within 3 months before enrollment
- •Patients with active autoimmune disease or stable disease with high risk of recurrence
- •Use corticosteroids (dose of prednisone or similar drugs> 10mg/day) or other immunosuppressive agents within 14 days before enrollment
- •Live vaccine was injected within 4 weeks before enrollment
- •Previously received treatment with EFFR-TKI
研究组 & 干预措施
Afatinib plus toripalimab
Experimental
干预措施: Afatinib (Drug)
Afatinib plus toripalimab
Experimental
干预措施: Toripalimab (Drug)
结局指标
主要结局
Objective response rate
时间窗: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
次要结局
- Incidence of Treatment-Related Adverse Events(Until 30 days after the last treatment)
- Progression free survival(Up to 2 years)
- Overall survival(Up to 2 years)
- Duration of response(Up to 2 years)
- Disease control rate(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
研究者
Shen Lin
Clinical Professor
Peking University Cancer Hospital & Institute
研究点 (1)
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