NCT05050760Unknown不适用
An Exploratory Study of the Efficacy and Safety of DCF Regimen Combined With Camrelizumab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma(ESCC)
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Safety and Feasibility（Incidence of Treatment-Emergent Adverse Events）
研究概览
简要总结
To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC
详细描述
Primary outcome:
To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC
Secondary outcome:
pathologic complete response (pCR)、Major Pathologic Response（MPR）、R0 resection rate、Objective response rate（ORR）、Disease free survival（DFS）、Relief rate and safety of dysphagia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old patients with esophageal cancer, male and female.
- •A patient with esophageal squamous cell carcinoma diagnosed by pathology.
- •Initial treatment, no previous surgery.
- •Subjects were patients with resectable locally advanced ESCC(AJCC V8 TNM classification),tumor node metastasis classification(TNM)
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale.
- •Expected survival ≥ 3 months.
- •All patients should have measurable or evaluable target lesions.
- •Able to eat more than a liquid diet; No preesophageal perforation signs; There was no distant metastasis and the operation was tolerated.
- •Demonstrate adequate organ function.
- •Male subjects whose partners are women of childbearing age should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study administration.
- •The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
排除标准
- •Patients who did not meet the inclusion criteria for pathological type and primary site.
- •Known to be allergic to macromolecular protein preparations, or components of carilizumab, or to loplatin, docetaxa, sergiol, contrast agents and their preparations.
- •Risk of esophageal perforation or presence of esophageal ulcers.
- •There is evidence of distant organ metastasis.
- •Surgical treatment (except biopsy), radiotherapy, chemotherapy, and molecular targeted therapy have been performed.
- •had other malignant tumors ever.
- •History of severe lung or heart disease.
- •Active infection or fever of unknown cause > 38.5℃ in the 2 weeks prior to randomization (fever due to tumor can be included in the study as determined by the investigator).
- •Significant active infection is known, or the investigator determines the presence of significant blood, renal, metabolic, gastrointestinal, or endocrine dysfunction.
- •Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- •Subjects requiring systematic treatment with corticosteroids (>10mg/ day of prednisone efficacy dose) or other immunosuppressive agents within 14 days prior to the first study drug. In the absence of active autoimmune disease, inhaled or topical steroid use and adrenal corticosteroid replacement at a dose >10mg/ day of prednisone efficacy dose were permitted.
- •Participants had active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), and hepatitis C (HCV antibody positive and HCV-RNA higher than the lower limit of the assay).
- •Those who had received live vaccine within 3 months prior to treatment.
- •In the midst of acute or chronic tuberculosis infection.
- •Patients were enrolled in clinical trials of other antitumor drugs within 4 weeks.
- •IV fluids cannot be administered.
- •She has a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation.
- •Have a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation
研究组 & 干预措施
The experimental group
Experimental
Drug：DCF+Camrelizumab Camrelizumab:200mg/time,IV,Q3W
干预措施: Camrelizumab (Drug)
The experimental group
Experimental
Drug：DCF+Camrelizumab Camrelizumab:200mg/time,IV,Q3W
干预措施: DCF (Drug)
结局指标
主要结局
Safety and Feasibility（Incidence of Treatment-Emergent Adverse Events）
时间窗: 12months
All participants with treatment-related adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Event,Version 5.0(CTC AE5.0).
次要结局
- Pathologic Complete Response (PCR)(1 month after resection)
- Major pathologic response (MPR)(1 month after resection)
- Disease Free Survival (DFS)(3 and 5 years)
研究者
研究点 (1)
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