NCT05771025招募中不适用
Effect of Hepatectomy on the Prognosis of Patients With Nasopharyngeal Carcinoma Liver Metastases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Overall survival time
研究概览
简要总结
The goal of this clinical trial is to learn about hepatectomy on the prognosis of patients with nasopharyngeal carcinoma liver metastases (NCLM). The main questions it aims to answer are:
To explore the effect of hepatectomy on the overall survival, recurrence-free survival and other prognostic indicators of patients with NCLM.
To explore the impact of hepatectomy on the safety of patients with NCLM.
Researchers will compare the prognosis of the patients in the hepatectomy group and the patients with NCLM who were prospectively enrolled in the same institution and received only systemic treatment at the same time by propensity score matching.
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
- •Nasopharyngeal carcinoma liver metastases (NCLM) are diagnosed by pathological confirmation of liver biopsy or imaging findings combined with clinical history.
- •ECOG score ≤ 2 points.
- •Patients with no recurrence of the primary tumor and oligometastasis in the liver.
- •Patients with multiple metastases (bone) without primary tumor recurrence and liver metastases have stable disease (SD) or partial remission (PR) or complete remission (CR) after systemic treatment except for liver lesions.
- •Patients with primary tumor recurrence and liver metastasis (may be combined with bone metastasis) have SD or PR or CR after systemic treatment except for liver lesions.
- •Able to perform radical resection of liver lesions.
- •Good liver function (Child-Pugh grade A liver function, estimated remaining liver volume ≥ 30%).
- •Blood test, coagulation function, liver and kidney function, electrocardiogram, chest X-ray and other preoperative examinations show no clear contraindications for surgery.
- •Expected survival ≥ 6 months.
- •Those who voluntarily participate in this study and signe the informed consent form.
排除标准
- •Younger than 18 or older than 70 years old.
- •ECOG score > 2 points.
- •Combined with distant metastasis other than liver and bone.
- •Disease progression (PD) after systemic treatment of the primary tumor and bone metastases.
- •The liver lesion cannot be resected by R
- •Insufficient liver reserve function (preoperative liver function Child-Pugh B or C grade and cannot be reduced to A grade in a short time, or estimated remaining liver volume <30%).
- •Combined with surgical contraindications in the preoperative examination, such as cardiac clinical symptoms or diseases that are not well controlled, abnormal coagulation function with bleeding tendency, or receiving thrombolytic therapy, etc..
- •Liver metastases have received local treatment for liver metastases such as interventional and radiofrequency.
- •Pregnant or lactating women.
- •History of malignant tumors in other parts, severe mental illness, etc..
- •Patients or family members cannot understand the conditions and objectives of this study.
结局指标
主要结局
Overall survival time
时间窗: up to 60 months
Refers to the time from liver resection to death from any cause.
次要结局
- Perioperative morbidity rate(3 months)
- Perioperative mortality rate(1 month)
- Unplanned reoperation rate(1 month)
- Intrahepatic recurrence-free survival(up to 60 months)
研究者
Lu Wang, MD, PhD
Professor
Fudan University
研究点 (1)
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