Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

NCT04544969 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Observational

Started

2020-04-01

Last updated

2025-01-28

Condition(s) studied

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

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

Trial sites (1)

Facility	City	Region	Status
Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting

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Other trials for the same condition

Screening Effect of Dual-energy CT Combined With Nasopharyngeal Endoscopy for Screening Nasopharyngeal Carcinoma Recruiting

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma Recruiting

An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC Starting soon

Radiotherapy Combined With Endostatin and Capecitabine for NPC Recruiting

Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma Active, not recruiting

Official registry record

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.

View NCT04544969 on ClinicalTrials.gov ↗ ← All trials in China