NCT04544969招募中不适用
Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年4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
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The coincidence rate between drug sensitivity test in CTCs and objective response rate
研究概览
简要总结
The prospective observational clinical study will recruit 50 metastatic nasopharyngeal carcinoma (mNPC) patients, detecting patient's chemosensitivity with the circulating tumor cells (CTCs) from peripheral blood and prdicting patient's treatment efficacy with CTCs dynamic change.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •NPC patients with distant metastasis after 3 months of primary radiotherapy, and not suitable for local treatment
- •At least having one measurable metastatic lesion
- •All genders，range from 18～70 years old
- •ECOG score 0 ~ 1
- •Expected survival time ≥ 3 months
- •White blood cell(WBC) count ≥ 3×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, hemoglobin(HGB) ≥ 90g/L, platelet(PLT) count ≥ 100×109/L
- •Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 2.5×upper limit of normal(ULN), bilirubin(BUN) or creatinine(CRE) < 1.5×ULN, alanine aminotransferase (CCR) ≥ 60ml/min
- •Inform consent form
排除标准
- •Have or are suffering from other malignant tumors;
- •Participating in other clinical trials;
- •Drug or alcohol addition;
- •Do not have full capacity for civil acts;
- •Mental disorder;
- •Pregnancy or lactation;
- •Severe complication, eg, uncontrolled hypertension.
研究组 & 干预措施
Chemotherapy
Patients treated with palliative chemotherapy
干预措施: cisplatin-based chemotherapy (Drug)
结局指标
主要结局
The coincidence rate between drug sensitivity test in CTCs and objective response rate
时间窗: 6 months
Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime
次要结局
- Cutoff value of CTC counts(Objective response at 6 months)
- Objective response rate(study period of 19 Months)
- The changes of CTCs countings(Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy)
- Progression free survival(baseline)
- Predictive value of the changes of CTCs countings(Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy)
研究者
Zhao Chong
Prof.
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Investigation of Multi-omics Technique to Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy for r/m NPCMulti-omics TechniqueRecurrent and Metastatic Nasopharyngeal CarcinomaEfficacy of Chemoradiotherapy and ImmunotherapyNasopharyngeal CarcinomaNCT06197776Sun Yat-sen University50
Unknown
不适用
A Study of Nasopharyngeal Carcinoma From GuangdongNasopharyngeal CancerNCT03003182Sun Yat-sen University2,000
已完成
不适用
Retrospective Study on the Prediction of Radiation-induced Brain Injury in Patients With Nasopharyngeal CarcinomaRadiation-Induced Temporal Lobe InjuryNasopharyngeal CarcinomaNCT06244394Jiangsu Cancer Institute & Hospital230
招募中
3 期
Nab-TPC vs GP Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal CarcinomaNasopharyngeal Cancinoma (NPC)NCT06669611Sun Yat-sen University242
Unknown
4 期
A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma PatientsMalignant Neoplasm of NasopharynxNCT02948699Zhejiang Cancer Hospital114