NCT06611826尚未招募2 期
A Prospective, Single-arm Phase II Clinical Study of GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy in Non-locally Treatable Recurrent Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 41
- 主要终点
- 3 year OS rate
研究概览
简要总结
This research aims to assess both effectiveness and safety of combining R-GEP regimen comprising gemcitabine, recombinant human endostatin, and cerexinib with low- and high-dose radiotherapy in managing unresectable recurrent nasopharyngeal carcinoma.
详细描述
Eligible patients will undergo screening before enrolling in this trial 。 The participants will receive R-GEP therapy according to specified dosing schedules over six cycles. Additionally administered low-dose radiotherapy during specific cycles serves to modulate immune microenvironment while high-dose fractionated radiotherapy follows completion of GEP therapy courses. Maintenance immunotherapy continues up until one year post-treatment conclusion or disease progression.Finally, the participants were evaluated accordingly。
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years;
- •ECOG performance status 0-2;
- •Pathological or clinical imaging diagnosis of recurrent nasopharyngeal carcinoma;
- •With imaging assessable lesions (assessed by RECIST 1.1 criteria);
- •Recurrent lesions are not eligible for curative local treatment (including but not limited to extensive invasion of recurrent lesions; recurrent lesions with obvious necrosis or ulceration, with bleeding risk; recurrent lesions extensively invading surrounding nerves/vessels or skin/muscle; obvious late radiation therapy complications after previous treatment: radiation-induced brain injury, posterior cranial nerve injury, dysphagia, severe myofibrosis; second or multiple courses of radiation therapy after recurrence or multiple recurrences);
- •The following requirements must be met for the function of major organs:
- •Hematological parameters tolerable to treatment: white blood cells ≥3.0×10^9/L, neutrophils ≥1.5×10^9/L, hemoglobin ≥9 g/dL, platelets ≥90×10^9/L.
- •Liver and kidney function: ALT, AST <1.5 times the upper limit of normal (ULN), total bilirubin <1.5×ULN, serum creatinine (Cr) ≤1.5×ULN; Echocardiographic assessment, left ventricular EF ≥50%;
- •The patient has signed an informed consent form and is willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other research procedures.
- •Voluntarily enroll in this study, sign an informed consent form, have good compliance and willingness to cooperate with follow-up.
排除标准
- •Subjects who cannot accept or tolerate chemotherapy or radiotherapy for various reasons;
- •Subjects who can be cured by definitive radiotherapy or surgery;
- •Subjects who have undergone major surgical procedures within the past 4 weeks or have not fully recovered from such procedures;
- •Subjects who are currently participating in other drug clinical trials;
- •Serious cardiac disease or discomfort, including but not limited to the following conditions:
- •History of congestive heart failure or impaired systolic function (LVEF <50%);
- •Uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate >100bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular conduction block (i.e., Mobitz Ⅱ second-degree atrioventricular conduction block or third-degree atrioventricular conduction block);
- •Angina requiring anti-angina drug therapy;
- •Clinically significant valvular heart disease;
- •ECG showing a penetrating myocardial infarction;
- •Uncontrolled hypertension (systolic blood pressure >180mmHg and/or diastolic blood pressure >100mmHg);
- •Subjects who have a history of hypersensitivity to any component of the study drug;
- •Any other situation in which the investigator deems the subject unsuitable to participate in the study.
研究组 & 干预措施
GEP
Experimental
Gemcitabine, recombinant human endostatin and carrilizumab combined with high-low dose radiotherapy
干预措施: GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy (Drug)
结局指标
主要结局
3 year OS rate
时间窗: 3 year
3 year OS rate
次要结局
- ORR(3year)
- DCR(3year)
- 3 year PFS rate(3 year)
研究者
Chen Xiaozhong
MD
Zhejiang Cancer Hospital
相似试验
Unknown
3 期
A Study to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Who Have Inadequate Glycemic Control on Metformin AloneDiabetes Mellitus, Type 2NCT04255238LG Chem468
进行中（未招募）
2 期
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Unresectable Biliary Tract CancerBiliary Tract CarcinomaInitially UnresectableNCT04984980Fudan University37
已完成
3 期
Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.dType 2 Diabetes MellitusNCT01787396LG Life Sciences433
已完成
2 期
Gleevec and Gemzar in Patients With Epithelial Ovarian CancerPrimary Peritoneal CancerOvarian CancerNCT00928642Henry M. Jackson Foundation for the Advancement of Military Medicine8
已完成
2 期
Gemcitabine Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines and/or TaxanesMetastatic Breast CancerNCT00192101Eli Lilly and Company100