search
Back to results

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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel（Albumin-bound）
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Paclitaxel(Album-bound)

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Objective response rate
    According to European Solid Tumor Efficacy Evaluation Standard (RECIST)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2021
    Last Updated
    February 24, 2021
    Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04769076
    Brief Title
    The Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Nasopharyngeal Carcinoma
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    4. Oversight

    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

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Paclitaxel(Album-bound)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Paclitaxel（Albumin-bound）
    Other Intervention Name(s)
    Cisplatin, PD-1 inhibitor (sintilimab), Radiotherapy
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Objective response rate
    Description
    According to European Solid Tumor Efficacy Evaluation Standard (RECIST)
    Time Frame
    1 month after the end of all treatments

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs