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.
Study Type
OBSERVATIONAL
Enrollment
50
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.
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe 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
Time frame: 6 months
The changes of CTCs countings
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Objective response at 6 months
Predictive value of the changes of CTCs countings
Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
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