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Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Recurrent Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Chemotherapy
endoscopic surgery
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Nasopharyngeal Carcinoma focused on measuring endoscopic surgery, Inductive chemotherapy

Eligibility Criteria

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

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

Sites / Locations

  • Fujian Medical University Union Hospital
  • Fujian Provincial Hospital
  • Shenzhen Second People's Hospital
  • The People's Hospital of Guangxi Zhuang Autonomous Region
  • The First Affiliated Hospital of Nanchang University
  • Eye& ENT Hospital, Fudan UniversityRecruiting
  • Shanghai Zhongshan Hospital,Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab and chemotherapy combined with endoscopic surgery

Arm Description

Camrelizumab and chemotherapy combined with endoscopic surgery

Outcomes

Primary Outcome Measures

Overall Survival
2 year Overall Survival rate

Secondary Outcome Measures

Local recurrence free survival
the date of first treatment to local failure or death
Progression free survival
the date of first treatment to the first recording of disease progression or death from any cause.
Rate of negative margin
negative margin rate according to pathology report
distant metastasis free survival
the date of first treatment to distant metastasis or death
pathologic complete remission
pathologic complete remission

Full Information

First Posted
August 7, 2021
Last Updated
August 25, 2021
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05011227
Brief Title
Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma
Official Title
A Prospective, Single-arm, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
August 10, 2025 (Anticipated)
Study Completion Date
August 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Nasopharyngeal Carcinoma
Keywords
endoscopic surgery, Inductive chemotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab and chemotherapy combined with endoscopic surgery
Arm Type
Experimental
Arm Description
Camrelizumab and chemotherapy combined with endoscopic surgery
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
2 cycles before endoscopic surgery and one year after
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
2 cycles before endoscopic surgery, with or without after surgery
Intervention Type
Procedure
Intervention Name(s)
endoscopic surgery
Intervention Description
standard endoscopic surgery for recurrent nasopharyngeal carcinoma
Primary Outcome Measure Information:
Title
Overall Survival
Description
2 year Overall Survival rate
Time Frame
From date of first treatment until the date of death from any cause, up to 4 years.
Secondary Outcome Measure Information:
Title
Local recurrence free survival
Description
the date of first treatment to local failure or death
Time Frame
From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.
Title
Progression free survival
Description
the date of first treatment to the first recording of disease progression or death from any cause.
Time Frame
From date of first treatment until the date of disease progression or death from any cause, up to 4 years.
Title
Rate of negative margin
Description
negative margin rate according to pathology report
Time Frame
At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.
Title
distant metastasis free survival
Description
the date of first treatment to distant metastasis or death
Time Frame
From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.
Title
pathologic complete remission
Description
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.
Other Pre-specified Outcome Measures:
Title
quality of life-（EORTC QLQ) - C30 version3.0
Description
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.
Time Frame
From date of first treatment to the end of study, at each visit, up to 4 years.
Title
quality of life-（EORTC QLQ) - H&N35
Description
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.
Time Frame
From date of first treatment to the end of study, at each visit, up to 4 years.
Title
adverse effect
Description
Using CTCAE Version5.0 to evaluate related adverse effect
Time Frame
From date of first treatment to the end of study, up to 4 years.
Title
immune related adverse effect
Description
Using CTCAE Version5.0 to evaluate immune related adverse effect
Time Frame
From date of first treatment to the end of study, up to 4 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaole Song, MD
Phone
15821388769
Email
jxfxsxl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongmeng Yu, MD,PHD
Organizational Affiliation
Eye&ENT Hospital,Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desheng Wang, MD
First Name & Middle Initial & Last Name & Degree
Haichun Lai, MD
First Name & Middle Initial & Last Name & Degree
Desheng Wang
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaopeng Huang
First Name & Middle Initial & Last Name & Degree
Shaopeng Huang
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongtian Lu
First Name & Middle Initial & Last Name & Degree
Yongtian Lu
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingjin Weng, PhD
First Name & Middle Initial & Last Name & Degree
Shenhong Qu
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Ye, MD
First Name & Middle Initial & Last Name & Degree
Jing Ye
Facility Name
Eye& ENT Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yan, MD
Phone
13761720601
Email
yanl13@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaoshen Wang, PHD
Facility Name
Shanghai Zhongshan Hospital,Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinsheng Huang
First Name & Middle Initial & Last Name & Degree
Xinsheng Huang

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

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