Circulating Tumor CellNasopharyngeal CarcinomaDistant Metastases.ClinicalEffects of Chemotherapy
Investigational drug(s) / intervention(s)
cisplatin-based chemotherapy
cisplatin-based chemotherapy: 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
The coincidence rate between drug sensitivity test in CTCs and objective response rate — 6 months Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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