Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC

May 8, 2022 updated by: Hongmeng Yu, Eye & ENT Hospital of Fudan University

A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma

A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

77

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
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • The First Affiliated Hospital of USTC（University of Science and Technology of China）
        • Contact:
          • Jingwu Sun, PhD
        • Principal Investigator:
          • Jingwu Sun, PhD
    • 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
        • Contact:
          • Jingjin Weng
        • Principal Investigator:
          • Shenhong Qu
    • 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:
        • Contact:
        • Principal Investigator:
          • Hongmeng Yu
        • Principal Investigator:
          • Xiaoshen Wang
      • 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
  • AJCC rT1-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 distant metastasis.
  • ≥6 months from the end of initial radiotherapy to recurrence.
  • Sufficient organ function a)Hematology: white blood cells ≥3.0 x 109/L, absolute neutrophil count ≥1.5x 109/L, hemoglobin ≥80 g/L, platelets ≥100 x 109/L. b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times the ULN c) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN. d) Renal function: serum creatinine ≤ 1.5 times ULN.
  • ECOG score 0-2. general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy.

Exclusion Criteria:

  • Evidence of distant metastasis or leptomeningel 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: endoscopic surgery combined with adjuvant immunotherapy
Procedure: endoscopic surgery
endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy
Other Names:
  • chemotherapy
  • adjuvant immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 2 years.
2 year progression free survival
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of enrollment until the date of death from any cause,through study completion,up to 2 years.
2 year Overall Survival rate
From date of enrollment until the date of death from any cause,through study completion,up to 2 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local progression free survival
Time Frame: From date of enrollment to local failure or date of death from any cause,through study completion,up to 2 years.
2 year Local progression free survival
From date of enrollment to local failure or date of death from any cause,through study completion,up to 2 years.
Distant metastasis free survival
Time Frame: From date of enrollment to distant metastasis or date of death from any cause, through study completion,up to 2 years.
2 year distant metastasis free survival
From date of enrollment to distant metastasis or date of death from any cause, through study completion,up to 2 years.
Toxicities
Time Frame: From date of enrollment through study completion,up to 2 years.
Using CTCAE Version5.0 to evaluate incidence of Treatment-Related Adverse Events including treatment related adverse effect and immune related adverse effect.
From date of enrollment through study completion,up to 2 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

Cancer Institute and Hospital, 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 (Anticipated)

May 8, 2022

Primary Completion (Anticipated)

May 8, 2026

Study Completion (Anticipated)

May 8, 2026

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 8, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rNPC-SA-Ad-Immuno-V1

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.

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