NCT04851132Unknown不适用
Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The incidence and mortality of esophageal cancer are at the forefront in China, among which the elderly patients account for a large proportion. Concurrent chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal cancer. Most elderly patients with esophageal cancer cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal cancer.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 70-85 years old, both men and women
- •Histologically confirmed esophageal squamous cell carcinoma located in thoracic segment, treatment naive
- •Stage cT2-4aNanyM0 (AJCC 8 TNM classification)
- •Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy
- •ECOG PS 0-2
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- •No severe abnormalities of the Hematologic system, heart, lung, liver, kidney, and immunodeficiency
- •Adequate bone marrow and organ function as defined below (excluding the use of any blood components and cell growth factors within 7 days):
- •Absolute neutrophil count≥1,500/mm3
- •Platelets ≥ 100,000/mm3
- •Hemoglobin ≥ 5.6 mmol/L (9g/dL)
- •Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥50 mL/min by Cockcroft-Gault estimation
- •Total bilirubin ≤ 1.5 x ULN
- •ALT and AST ≤ 2.5 x ULN
- •Proteinuria < 2+, for subjects with urine protein ≥ 2 + at baseline, urine samples should be collected within 24 hours and urine protein in 24 hours should be ≤ 1g
- •INR or PT or aPTT ≤ 1.5 x ULN
- •Life expectancy more than 6 months
- •Ability to understand and willingness to sign an IRB approved written informed consent document, and capable of proper therapeutic compliance, and accessible to correct follow-up
排除标准
- •Complete esophageal obstruction that unable to eat fluid and cannot provide necessary nutrition through nasal feeding
- •Patients with obvious ulcer or esophageal perforation or hematemesis
- •Placement of esophagotracheal stents
- •Has a history or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumonoconiosis, drug-associated pneumonia, severe impairment of pulmonary function
- •Has had major surgery within 28 days prior to the start of the treatment
- •Immunosuppressive drugs used within 4 weeks prior to the initial study treatment, excluding local glucocorticoids, or systemic glucocorticoids at physiological doses (i.e., no more than 10 mg/ day of prednisone or equivalent doses of other glucocorticoids);
- •The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, glomerulonephritis, thyroiditis (patients with vitiligo or asthma has been completely relieved in childhood, and do not need any intervention during adulthood can be included; patients with type I diabetes with good insulin control can also be included; hypothyroidism caused by autoimmune thyroiditis requiring hormone replacement therapy can also be included)
- •Has had congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (HCV-RNA ≥ 103 copies/ml; For chronic hepatitis B virus carriers, HBV viral load must be < 2000 IU/ml (< 104 copies / ml), and must receive antiviral therapy at the same time before they can be enrolled
- •Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
- •Uncontrolled clinically significant disease, including active infection, uncontrolled hypertension, unstable angina pectoris, angina within the past 3 months, heart failure > NYHA II, myocardial infarction within the past 6 months, severe arrhythmias requirement for treatment or intervention, liver/kidney or metabolic disease
- •System infections that require treatment
- •Received a live vaccine within 4 weeks of the first dose of study medication
- •Synchronous or metachronous second primary malignancy. Participants with basal cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded from the study
- •Patients who have participated in other clinical trials within 30 days
- •Drug addiction, chronic alcoholism and AIDS
- •Patients with uncontrollable seizures or loss of self-control due to mental illness
- •Those with a history of severe allergy or specific physique
- •The investigators judge not suitable for inclusion
研究组 & 干预措施
Exprimental Arm
Experimental
IMRT plus Durvalumab
干预措施: Radiotherapy (Radiation)
Exprimental Arm
Experimental
IMRT plus Durvalumab
干预措施: Durvalumab (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 1-year
PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
次要结局
- Overall survival (OS)(1-, 2- and 3-year)
- Progression-free survival (PFS)(2- and 3-year)
- Objective Response Rate (ORR)(during the intervention up to 60 weeks)
- Disease Control Rate (DCR)(during the intervention up to 60 weeks)
- Number of participants with an adverse event(Up to 60 weeks)
- Quality of Life (QOL): questionnaire EORTC QLQ-C30 (version 3)(up to 60 weeks)
研究者
Zhouguang Hui, M.D.
Chief physician, Director of VIP Department
Chinese Academy of Medical Sciences
研究点 (1)
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