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NCT Number: NCT04544969

Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: docetaxel and cisplatin, fluorouracil and cisplatin, docetaxel, fluorouracil and cisplatin, gemcitabine and cisplatin

Primary outcomes

  1. The coincidence rate between drug sensitivity test in CTCs and objective response rate

    Time frame: 6 months

    Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime

Secondary outcomes

  1. The changes of CTCs countings

    Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy

  2. Objective response rate

    Time frame: study period of 19 Months

    To be determined by measurement of target lesions according to RECIST criteria

  3. Progression free survival

    Time frame: baseline

    Defined as the time in months from first course of treatment until PD is observed or death occurs due to any cause.

  4. Cutoff value of CTC counts

    Time frame: 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

  5. Predictive value of the changes of CTCs countings

    Time frame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Jingjing Miao, M.D

CONTACT

[email protected]

86-13631355201

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Sep 10, 2020
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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