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

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ClinicalTrials.gov Identifier: NCT04769076
Recruitment Status : Not yet recruiting
First Posted : February 24, 2021
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Combination Product: Paclitaxel（Albumin-bound） Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Clinical Trial of Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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）
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
Other Names:
  • Cisplatin
  • PD-1 inhibitor (sintilimab)
  • Radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 1 month after the end of all treatments ]
    According to European Solid Tumor Efficacy Evaluation Standard (RECIST)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yang Yang, Professor of medicine, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT04769076    
Other Study ID Numbers: 2020-241-02
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
 Stomatognathic Diseases
Otorhinolaryngologic Diseases
Paclitaxel
Cisplatin
Immune Checkpoint Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action