Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

NCT04544969 | Recruiting DMC

• 1 other identifier: B2019-128
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Circulating Tumor Cell; Nasopharyngeal Carcinoma; Distant Metastases.Clinical; Effects of Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Progression free survival

  baseline

• Cutoff value of CTC counts

  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

Study Arms (1)

Chemotherapy

Patients treated with palliative chemotherapy

Drug: cisplatin-based chemotherapy

Interventions

cisplatin-based chemotherapy DRUG

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.

Also known as: docetaxel and cisplatin, fluorouracil and cisplatin, docetaxel, fluorouracil and cisplatin, gemcitabine and cisplatin

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NPC patients with distant metastasis after 3 months of primary radiotherapy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Links

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

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Nasopharyngeal Carcinoma

Interventions

Docetaxel; Cisplatin; Fluorouracil; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Study Officials

• Chong Zhao, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingjing Miao, M.D

CONTACT

86-13631355201; miaojingjing90@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: September 10, 2020
• Study Start: April 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)