Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma; Circulating Tumor Cell; Effects of Chemotherapy; Distant Metastases.Clinical
• Intervention / Treatment: Drug: cisplatin-based chemotherapy

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Jingjing Miao, M.D; Phone Number: 86-13631355201; Email: miaojingjing90@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Cancer Center, Sun Yat-sen University
      • Contact: Chong Zhao; Phone Number: 02087342638; Email: zhaochong@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

NPC patients with distant metastasis after 3 months of primary radiotherapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Chong Zhao, M.D, Sun Yat-sen University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes; Neoplasm Metastasis; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Neoplastic Cells, Circulating; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gemcitabine; Docetaxel; Cisplatin; Fluorouracil
• Other Study ID Numbers: B2019-128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No