About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial population
NPC patients with distant metastasis after 3 months of primary radiotherapy
Trial design
Case-only
Prospective
Treatments tested in this trial
cisplatin-based chemotherapy
DrugGP: 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
The changes of CTCs countings
Objective response rate
To be determined by measurement of target lesions according to RECIST criteria
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.
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.