Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04544969

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Circulating Tumor Cell Nasopharyngeal Carcinoma Distant Metastases.Clinical Effects of Chemotherapy	Drug: cisplatin-based chemotherapy

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Chemotherapy Patients treated with palliative chemotherapy	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. Other Names: docetaxel and cisplatin fluorouracil and cisplatin docetaxel, fluorouracil and cisplatin gemcitabine and cisplatin

Arm

Intervention/Treatment

Chemotherapy

Patients treated with palliative chemotherapy

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.

Other Names:

docetaxel and cisplatin

fluorouracil and cisplatin

docetaxel, fluorouracil and cisplatin

gemcitabine and cisplatin

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The changes of CTCs countings [Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy]
Objective response rate [study period of 19 Months]
To be determined by measurement of target lesions according to RECIST criteria
Progression free survival [baseline]
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 [Objective response at 6 months]
to identify patients with early relapse (<6 months) after liver resection as determined by the AUC under the ROC curve
Predictive value of the changes of CTCs countings [Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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
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