Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04544969
• Other study ID #: B2019-128
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Jingjing Miao, M.D
• Phone: 86-13631355201
• Email: miaojingjing90[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Circulating Tumor Cell
• Distant Metastases.Clinical
• Effects of Chemotherapy
• Nasopharyngeal Carcinoma
• Neoplastic Cells, Circulating

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The changes of CTCs countings		Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
Secondary	Objective response rate	To be determined by measurement of target lesions according to RECIST criteria	study period of 19 Months
Secondary	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
Secondary	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
Secondary	Predictive value of the changes of CTCs countings		Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy

External Links

•   Home Page of Cancer Center, Sun Yat-sen University