Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

Study Overview
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Brief Summary
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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.

Official Title
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Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients

Conditions
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Circulating Tumor Cell, Nasopharyngeal Carcinoma, Distant Metastases.Clinical, Effects of Chemotherapy

Intervention / Treatment
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* Drug: cisplatin-based chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy<br>Patients treated with palliative chemotherapy | Drug: cisplatin-based chemotherapy<br>* GP: cisplatin 80 mg/m2 intravenous infusion on day1, gemcitabine 1000 mg/m2 intravenous infusion on day 1 and 8, both drugs are given every 3 weeks, recommended 6 cycles. TP: cisplatin 75 mg/m2 intravenous infusion in day1, docetaxel 75 mg/m2 intravenous infusion in day 1, both drugs are given every 3 weeks, recommended 6 cycles. PF: cisplatin 100 mg/m2 intravenous infusion in day1, fluorouracil 4000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles. TPF: cisplatin 60 mg/m2 intravenous infusion in day1, docetaxel 60 mg/m2 intravenous infusion in day 1, fluorouracil 3000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles. Choice of chemotherapy regimen is decided by patient's doctor in charge.<br>* Other names: gemcitabine and cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The coincidence rate between drug sensitivity test in CTCs and objective response rate | Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of CTCs countings |  | Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy | 
| Objective response rate | To be determined by measurement of target lesions according to RECIST criteria | study period of 19 Months | 
| Progression free survival | Defined as the time in months from first course of treatment until PD is observed or death occurs due to any cause. | baseline | 
| Cutoff value of CTC counts | to identify patients with early relapse (<6 months) after liver resection as determined by the AUC under the ROC curve | Objective response at 6 months | 
| Predictive value of the changes of CTCs countings |  | Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy |