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Nasopharyngeal CarcinomaPhase 2NCT04004871

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

A Phase 2 study testing Nab-paclitaxel, Cisplatin and Fluorouracil and concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Guangxi Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Nab-paclitaxel, Cisplatin and Fluorouracil and concurrent chemoradiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
28 Mar 2019to 31 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

Other trials in China

About this study

Official 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

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.

Being tested
Nab-paclitaxel, Cisplatin and Fluorouracil, concurrent chemoradiotherapy
Medical subject headings
Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nab-paclitaxel, Cisplatin and FluorouracilDrug

    Also called APF induction chemotherapy

    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.

  • concurrent chemoradiotherapyRadiation

    Also called Radical radiotherapy and concurrent cisplatin

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

Study groups in NCT04004871
Study groupRoleWhat they receive
Induction chemotherapy and concurrent chemoradiotherapyExperimentalPatients receive induction chemotherapy with Nab-paclitaxel, cisplatin and fluorouracil every three weeks for three cycles before radiotherapy, and then receive concurrent chemoradiotherapy.
Receives: Drug: Nab-paclitaxel, Cisplatin and Fluorouracil; Radiation: concurrent chemoradiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

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

    Measured: 3 years

Secondary outcomes (3)

  1. Failure-free survival (FFS)

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

    Measured: 3 years

  2. Overall survival（OS）

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

    Measured: 3 years

  3. Adverse Events

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2019
  2. Study start28 Mar 2019
  3. Primary completion29 Mar 2022
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04004871
Sponsor's protocol ID
GuangxiMUHK1
Status last verified
Nov 2025
First submitted
26 Jun 2019
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel, Cisplatin and Fluorouracil and concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Guangxi Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04004871.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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