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

February 24, 2021 updated by: Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Radiotherapy
  • Cisplatin
  • PD-1 inhibitor (sintilimab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 1 month after the end of all treatments
According to European Solid Tumor Efficacy Evaluation Standard (RECIST)
1 month after the end of all treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (ACTUAL)

February 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-241-02

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nasopharyngeal Carcinoma

Clinical Trials on Paclitaxel（Albumin-bound）

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe