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NCT Number: NCT04004871

Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is commonly observed in southern China, particularly in the Pearl River delta area and the Xijiang River basin in the Guangdong and Guangxi provinces, with an incidence rate as high as 25-50 per 100,000. The National Comprehensive Cancer Network guidelines (version 1, 2018), have recommended use of induction chemotherapy followed by CCRT as category 2A for NPC, especially the TPF regimen as category 1 for EBV-associated disease. The nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a promising new agent with more efficient entry to the tumor microenvironment and preferential uptake by cancer cells. Superior activity of Nab-paclitaxel regimens without the necessity for antianaphylactic pretreatments has been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of Nab-paclitaxel, cisplatin and Fluorouracil (APF) has not been determined in patients with locoregionally advanced NPC. In this prospective, Multi-centeric, Open, Non-controlled phase II clinical trial, investigators perform an exploratory study to the efficacy and Safety of APF.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Cancer Nasopharyngeal Diseases Nasopharyngeal Neoplasms Nasopharynx Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
  • Tumor staged as T3-4/N1-3 (according to the 8th UICC edition).
  • No evidence of distant metastasis (M0).
  • EBV positive.
  • Satisfactory performance status: ECOG≤2.
  • Adequate marrow: leucocyte count ≥4000/uL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  • Adequate renal function: creatinine clearance ≥60 ml/min.
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion criteria

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age>60 years or <18 years.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation.
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Treatment and study plan

Nab-paclitaxel, Cisplatin and Fluorouracil

Drug

Patients receive Nab-paclitaxel (200mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before concurrent chemoradiotherapy.

Other names: APF induction chemotherapy

concurrent chemoradiotherapy

Radiation

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Other names: Radical radiotherapy and concurrent cisplatin

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 3 years

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

Secondary outcomes

  1. Failure-free survival (FFS)

    Time frame: 3 years

    From the date of registration to the date of either locally, regionally or distant failure or last follow-up

  2. Overall survival（OS）

    Time frame: 3 years

    From the date of registration to the date of death is observed or to last follow-up visit

  3. Adverse Events

    Time frame: 3 years

    Incidence of Treatment-Emergent Adverse Events Evaluated according to NCI-CTC AE V4.03

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Collaborators

  • Liuzhou Workers' Hospital
  • Wuzhou Red Cross Hospital

Registry information

Official study title

The Efficacy and Safety of Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil, Concurrent Chemotherapy of Cisplatin and IMRT in Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multi-centeric, Open, Non-controlled, Phase II Clinical Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Jul 2, 2019
Registry last updated
Dec 11, 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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