Adjuvant vs Surgery Only in Early-stage Recurrent NPC

July 1, 2025 updated by: Eye & ENT Hospital of Fudan University

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.

Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • Phase 3

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

  • Name: Xiaole Song, MD
  • Phone Number: +8621 64377134
  • Email: jxfxsxl@163.com

Study Contact Backup

  • Name: Yuting Lai

Study Locations

  • China
      • Fuzhou, China
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Principal Investigator:
          • Desheng Wang
        • Contact:
          • Desheng Wang
        • Sub-Investigator:
          • Haichun Lai
      • Nanning, China
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Principal Investigator:
          • Shenhong Qu
        • Contact:
          • Shenhong Qu
        • Sub-Investigator:
          • Jingjin Weng
      • Shanghai, China
        • Recruiting
        • Changhai Hospital
        • Contact:
          • Haihong Tang
        • Principal Investigator:
          • Haihong Tang
        • Sub-Investigator:
          • Hongliang Zheng
        • Sub-Investigator:
          • Haopu Li
        • Sub-Investigator:
          • Fengya Pan
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
          • Xinsheng Huang
        • Principal Investigator:
          • Xinsheng Huang
        • Principal Investigator:
          • Xianhui Ning
        • Principal Investigator:
          • Lei Zhou
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
          • Weitian Zhang
        • Principal Investigator:
          • Weitian Zhang
        • Sub-Investigator:
          • Ru Tang
      • Shenzhen, China
        • Not yet recruiting
        • Shenzhen Second People's Hospital
        • Contact:
          • Yongtian Lu
        • Principal Investigator:
          • Yongtian Lu
        • Principal Investigator:
          • Jing Tao
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Eye& ENT Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Hongmeng Yu
        • Sub-Investigator:
          • Li Yan
        • Sub-Investigator:
          • Xiaole Song
        • Sub-Investigator:
          • Yuting Lai

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
  2. Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery >5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
  3. Cervical lymph node metastasis can be controlled locally
  4. Age 18 to 75 years;
  5. Without distant metastasis;
  6. Informed consent forms signed;
  7. ≥6months from the accomplishment of radiation to recurrence
  8. previously radiotherapy for only 1 course;
  9. ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
  10. Sufficient organ function;
  11. Undergone endoscopic surgery with negative pathological margin;

Exclusion Criteria:

  1. Participation in other interventional clinical trials;
  2. Uncontrolled illnesses which will interfere with the ability to undergo therapy;
  3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
  4. Any contradiction to immune and chemotherapy;
  5. With serious autoimmune disease;
  6. Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
  7. Severe allergic reactions to other monoclonal antibodies;
  8. History of radioactive particle planting;
  9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
  10. Female patients who are at pregnancy or lactation;
  11. Other situations that the researchers believe are not suitable for enrollment

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The control group
Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery.
Experimental: The experimental group
Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.
Drug: Immunotherapy,Toripalimab Injection
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Drug: Chemotherapy,Gemcitabine based regimen
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months
Disease free survival
From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From randomization to death of any cause,assessed up to 60 months
Overall Survival
From randomization to death of any cause,assessed up to 60 months
LRFS
Time Frame: From randomization to local recurrence or death,assessed up to 24 months
Local recurrence free survival
From randomization to local recurrence or death,assessed up to 24 months
DMFS
Time Frame: From randomization to distant metastasis or death, assessed up to 24 months
Distant metastasis free survival
From randomization to distant metastasis or death, assessed up to 24 months
1-and 2-year DFS rate
Time Frame: end of 1st year, end of 2nd year
one- and two-year disease free survival
end of 1st year, end of 2nd year
1-and 2-year OS rate
Time Frame: end of 1st year, end of 2nd year
one- and two-year overall survival rate
end of 1st year, end of 2nd year

Collaborators and Investigators

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

Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

Changhai Hospital
Shanghai Zhongshan Hospital
Fujian Medical University Union Hospital
Shenzhen Second People's Hospital
Shanghai 6th People's Hospital
People's Hospital of Guangxi Zhuang Autonomous Region

Investigators

  • Principal Investigator: Hongmeng Yu, 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)

June 25, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • early-rNPC-RCT-adj

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • 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

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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