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Not yet recruitingNCT04769076Updated Feb 25, 2021

The Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Nasopharyngeal Carcinoma

A Phase 2 interventional study of Paclitaxel（Albumin-bound） in Nasopharyngeal Carcinoma, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-25.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study in to observe the effectiveness and safety of paclitaxel (albumin-bound type) combined with cisplatin, PD-1 inhibitor and IMRT in the treatment of locally advanced nasopharyngeal carcinoma.

Read the detailed description

This trial is a prospective, open, single-arm phase II clinical trial. The trial will enroll 40 patients with nasopharyngeal cancer stage III-IVA (UICC 8th edition). Subjects will receive paclitaxel (albumin-bound) combined with cisplatin and PD-1 inhibitor (sintilimab) neoadjuvant therapy and radical concurrent chemotherapy and radiotherapy.

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Conditions studied

  • Nasopharyngeal Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma
  • The stage is Ⅲ-ⅣA (UICC 8th edition)
  • Initial treatment patients without anti-tumor therapy
  • No history of other malignant tumors
  • Male or female, aged 18\~70 years old
  • Sufficient liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min
  • Sufficient blood function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL
  • No serious heart, lung, liver, kidney and other important organ dysfunction
  • Karnofsky score ≥70 points
  • No autoimmune diseases
  • Sign informed consent

Exclusion criteria

Exclusion Criteria:

  • Has performed anti-tumor treatment, including chemotherapy, radiotherapy, and surgery
  • Discovery of distant metastases before treatment
  • Receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period
  • Active, known or suspected autoimmune diseases
  • Known history of primary immunodeficiency
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
  • Women who are pregnant or breastfeeding
  • Disagree to sign the informed consent form
  • Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons
  • Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research)
  • Known allergic to possible chemotherapy drugs
  • Accompanied by serious uncontrollable infections or medical diseases
  • Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, unable to tolerate radiotherapy and chemotherapy
  • Laboratory examination: total bilirubin>upper limit of normal (ULN); AST and/or ALT>1.5 times ULN and accompanied by alkaline phosphatase>2.5 times ULN
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Paclitaxel(Album-bound)

    Subjects will receive neoadjuvant therapy with paclitaxel (albumin-bound) combined with cisplatin and PD-1 inhibitor (sintilimab) as well as radical concurrent radiotherapy and chemotherapy.

    Combination Product: Paclitaxel（Albumin-bound）

Interventions

  • Combination productPaclitaxel（Albumin-bound）

    Three courses of albumin-bound paclitaxel combined with cisplatin and PD-1 monoclonal antibody neoadjuvant treatment followed by cisplatin combined with IMRT (intensity modulated conformal radiotherapy) concurrent radiotherapy and chemotherapy

    Also known as: Cisplatin, PD-1 inhibitor (sintilimab), Radiotherapy

06

What researchers measure

Primary outcomes

  1. Objective response rate

    According to European Solid Tumor Efficacy Evaluation Standard (RECIST)

    Time frame: 1 month after the end of all treatments

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04769076
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Yang Yang (Professor of medicine, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Feb 24, 2021
Start date
Mar 1, 2021 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Feb 25, 2021

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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