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Status unknownNCT04015661Updated Jul 11, 2019

Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC

A Phase 2 interventional study of Nab-paclitaxel in Nasopharyngeal Carcinoma, sponsored by Fuzhou General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-11.

Sponsored by Fuzhou General Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
92
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts of the world. According to the World Health Organization survey, 80% of nasopharyngeal carcinomas occur in China, with high incidence in southern China, as high as 30-50/100,000, such as Guangdong, Guangxi, Hunan, and Fujian. In 2015, Chinese cancer statistics showed that there were about 60,600 new cases of nasopharyngeal carcinoma in China, and the number of deaths was about 34,100. Radiation therapy is the main treatment for nasopharyngeal carcinoma. Early stage I and IIa achieved a 5-year survival rate (OS) of 90% and 84%, respectively . However, the treatment outcomes of most patients with locally advanced nasopharyngeal carcinoma are not ideal.

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Conditions studied

  • Nasopharyngeal Carcinoma
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In context

Nasopharyngeal Carcinoma

824 studies on the registry are indexed under Nasopharyngeal Carcinoma; 281 are open to participants now.

This study's planned enrollment of 92 is close to the median of 84 across 674 interventional studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Fuzhou General Hospital is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age, 18-75 years old.
  2. Patients with newly histologically confirmed NPC.
  3. WHO Type Ⅱ and Ⅲ.
  4. Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
  5. No serious organ dysfunction of heart, lung, liver, kidney.
  6. No distant metastasis.
  7. Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.
  8. 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 ≤1.5×ULN,creatinine clearance ≥60 ml/min.
  9. Patients must be given written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. age >75 years or \<18years.
  2. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  3. History of previous radiotherapy and chemotherapy.
  4. Known or suspected to be allergic to platinum and Nab-paclitaxel.
  5. Pregnancy or lactation.
  6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
  7. Peripheral sensory neuropathy> grade 1.
  8. Uncontrolled heart clinical symptoms or diseases.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Nab-paclitaxel+Nedaplatin

    induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

    Drug: Nab-paclitaxel

  • Active comparator
    Paclitaxel+Nedaplatin

    induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

    Drug: Nab-paclitaxel

Interventions

  • induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy

    Also known as: Paclitaxel for Injection (Albumin Bound)

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What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

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

    Time frame: 3 years

Secondary outcomes

  1. Progression-Free Survival(PFS)

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

    Time frame: 3 years

  2. Overall survival(OS)

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

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
  • No. 156, North Road, Xierhuan Road
    Fuzhou, Fujian, China
    • wenmin ying, bachelor · Contact · 15080015210
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04015661
Lead sponsor
Fuzhou General Hospital
Responsible party
Sponsor
First posted
Jul 11, 2019
Start date
Jul 9, 2019 (estimated)
Primary completion
Dec 1, 2020 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Jul 11, 2019

Study contacts

wenmin ying, bachelor
Contact
18352770@qq.com
228 59125
xiaoyan li
Contact
228 59125
zhichao fu, M.D
study chair · Fuzhou General Hospital of Nanjing Military Regio,Department of Radiotherapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Albumin-Bound Paclitaxel

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