Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

March 4, 2024 updated by: Eye & ENT Hospital of Fudan University

A Prospective, Single-arm, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma

To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Desheng Wang, MD
        • Contact:
          • Haichun Lai, MD
        • Principal Investigator:
          • Desheng Wang
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Provincial Hospital
        • Contact:
          • Shaopeng Huang
        • Principal Investigator:
          • Shaopeng Huang
    • Guangdong
      • Shenzhen, Guangdong, China
        • Not yet recruiting
        • Shenzhen Second People's Hospital
        • Contact:
          • Yongtian Lu
        • Principal Investigator:
          • Yongtian Lu
    • Guangxi
      • Nanning, Guangxi, China
        • Not yet recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Principal Investigator:
          • Shenhong Qu
        • Contact:
          • Jingjin Weng, PhD
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Jing Ye, MD
        • Principal Investigator:
          • Jing Ye
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Eye& ENT Hospital, Fudan University
        • Contact:
        • Sub-Investigator:
          • Xiaoshen Wang, PHD
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Shanghai Zhongshan Hospital,Fudan University
        • Contact:
          • Xinsheng Huang
        • Principal Investigator:
          • Xinsheng Huang

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically confirmed recurrent nasopharyngeal carcinoma
  • American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent T4 which can be surgically removed
  • Age ≥18 years old
  • Informed consent signed
  • With or without lymph node metastasis, which can be surgically removed
  • No massive hemorrhage risk recently
  • No distant metastasis
  • ≥6 months from initial radiotherapy to recurrence
  • Radical radiation only once
  • Sufficient organ function
  • Eastern Cooperative Oncology Group score 0-2

Exclusion Criteria:

  • With a history of allergic to platinum drugs and similar compounds
  • Evidence of distant metastasis or radiation encephalopathy or leptomeningeal disease (LMD)
  • Have received radioactive seed implantation in the treatment area
  • Suffer from uncontrolled disease which could interfere with treatment
  • Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.)
  • The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on
  • The patients have autoimmune diseases
  • The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration
  • Severe allergic reaction to other monoclonal antibodies
  • Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment
  • Live vaccines have been inoculated within 4 weeks before the first administration or during the study period
  • The patient has any situation that may hinder study compliance or the safety during the study period
  • Existence of serious neurological or psychiatric diseases, such as dementia and seizures
  • Uncontrolled active infection
  • Pregnant or breastfeeding women
  • Those who have no personal freedom and independent capacity for civil conduct
  • There are other situations that are not suitable for entry into the study

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Camrelizumab and chemotherapy combined with endoscopic surgery
Procedure: endoscopic surgery
standard endoscopic surgery for recurrent nasopharyngeal carcinoma
Drug: Camrelizumab
2 cycles Camrelizumab before endoscopic surgery and one year after
Drug: Chemotherapy
2 cycles Gemcitabine based chemotherapy before endoscopic surgery, with or without after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of first treatment until the date of death from any cause, up to 4 years.
2 year Overall Survival rate
From date of first treatment until the date of death from any cause, up to 4 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence free survival
Time Frame: From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.
the date of first treatment to local failure or death
From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.
Progression free survival
Time Frame: From date of first treatment until the date of disease progression or death from any cause, up to 4 years.
the date of first treatment to the first recording of disease progression or death from any cause.
From date of first treatment until the date of disease progression or death from any cause, up to 4 years.
Rate of negative margin
Time Frame: At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.
negative margin rate according to pathology report
At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.
distant metastasis free survival
Time Frame: From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.
the date of first treatment to distant metastasis or death
From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.
pathologic complete remission
Time Frame: At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.
pathologic complete remission
At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life-（EORTC QLQ) - C30 version3.0
Time Frame: From date of first treatment to the end of study, at each visit, up to 4 years.
using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ) - C30 version3.0. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
From date of first treatment to the end of study, at each visit, up to 4 years.
quality of life-（EORTC QLQ) - H&N35
Time Frame: From date of first treatment to the end of study, at each visit, up to 4 years.
using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ）- H&N35，All of the scales and single-item measures range in score from 0 to 100. For all the scales and single-items a high score represents a high level of symptomatology or problems.
From date of first treatment to the end of study, at each visit, up to 4 years.
adverse effect
Time Frame: From date of first treatment to the end of study, up to 4 years.
Using CTCAE Version5.0 to evaluate related adverse effect
From date of first treatment to the end of study, up to 4 years.
immune related adverse effect
Time Frame: From date of first treatment to the end of study, up to 4 years.
Using CTCAE Version5.0 to evaluate immune related adverse effect
From date of first treatment to the end of study, up to 4 years.

Collaborators and Investigators

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

Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Hongmeng Yu, MD,PHD, Eye&ENT Hospital,Fudan University

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 (Actual)

August 10, 2021

Primary Completion (Estimated)

August 10, 2025

Study Completion (Estimated)

August 10, 2025

Study Registration Dates

First Submitted

August 7, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rNPC-SA-Neo-Cam-V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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