NCT06491134尚未招募1 期
Phase Ib Trial of Liposomal Irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
Hebei Medical University Fourth Hospital0 个研究点目标入组 12 人开始时间: 2024年6月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- maximum tolerable dose (MTD)
研究概览
简要总结
Observation of maximum tolerable dose (MTD), dose limiting toxicity (DLT), and phase II clinical recommended dose (RP2D) of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal squamous cell carcinoma. Evaluate the efficacy and safety of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and be willing to sign written informed consent and be able to follow research protocols for treatment.
- •Age 18-75 years.
- •Histologically confirmed cT2-T4a,N0-N+,M0 Esophageal Squamous Carcinoma.
- •Existence of measurable and/or unmeasurable lesions that meet the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
- •No previous anti-tumor therapy for esophageal cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Life expectancy ≥ 3months
- •Adequate organ and bone marrow function measured within14 days prior to administration of study treatment as defined below:
- •Haemoglobin ≥ 90g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Total bilirubin ≤institutional upper limit of normal Aspartate aminotransferase (AST(SGOT)/Alanine transaminase (ALT)SGPT) ≤ 2.5 x institutional upper limit of normal Serum creatinine ≤ 1.2mg/dL And creatinine clearance ≥50mL/min (Cockcroft-Gault formula)
- •Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, childbearing age Women/men should take effective contraceptive measures.
排除标准
- •patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma.
- •Allergic to cisplatin.
- •Patients with a history of esophageal squamous cell carcinoma surgery.
- •A history of fistula caused by primary tumor infiltration.
- •Have higher, esophageal fistula or esophageal perforation of gastrointestinal bleeding risk.
- •Poor nutritional status, BMI < 18.5kg/m2, or PG-SGA score ≥
- •Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment.
- •Patients with active hepatitis B, hepatitis C, syphilis.
- •major cardiovascular disease, including any of the following:
- •Within 6 months before enrollment, congestive heart failure (defined as New York Heart Association grade III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass grafting, cerebrovascular accident, or hypertensive crisis.
- •A history of clinically significant ventricular arrhythmias
- •Friderica-modified QT interval >450 msec in men and >470 msec in women
- •History of congenital long QT syndrome or family history
- •Arrhythmias requiring antiarrhythmic drug therapy
- •History of deep vein thrombosis, pulmonary embolism, or any other major thromboembolism within 3 months before enrollment
- •Severe prolonged diarrhoea.
- •Severe mental illness.
- •Use of strong inhibitors or inducers such as CYP3A4, CYP2C8 and UGT1A
- •Participate in other trials within 4 weeks before the start of the trial.
- •The investigators believe that patients were inappropriate for participation.
研究组 & 干预措施
liposomal irinotecan
Experimental
liposomal irinotecan With Cisplatin and Concurrent Radiotherapy
干预措施: Liposomal Irinotecan Hydrochloride (Drug)
结局指标
主要结局
maximum tolerable dose (MTD)
时间窗: through study completion, an average of 1 year
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing dose-limiting
次要结局
- Progress-free survival(PFS)(2-years)
- Objective response rate (ORR)(Within 28 days of the end of treatment)
研究者
Jun wang
offices director
Hebei Medical University Fourth Hospital
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