Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

Recruiting

• Conditions: Circulating Tumor Cell; Nasopharyngeal Carcinoma; Distant Metastases.Clinical; Effects of Chemotherapy
• Interventions: Drug: cisplatin-based chemotherapy

• Registration Number: NCT04544969
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy	cisplatin-based chemotherapy	Patients treated with palliative chemotherapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Objective response rate	study period of 19 Months	To be determined by measurement of target lesions according to RECIST criteria
The changes of CTCs countings	Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
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.
Predictive value of the changes of CTCs countings	Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China