Adjuvant vs Surgery Only in Early-stage Recurrent NPC
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
1 other identifier
interventional
176
1 country
7
Brief Summary
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2024
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedStudy Start
First participant enrolled
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
July 4, 2025
July 1, 2025
4 years
December 21, 2023
July 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
DFS
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 Outcomes (5)
OS
From randomization to death of any cause,assessed up to 60 months
LRFS
From randomization to local recurrence or death,assessed up to 24 months
DMFS
From randomization to distant metastasis or death, assessed up to 24 months
1-and 2-year DFS rate
end of 1st year, end of 2nd year
1-and 2-year OS rate
end of 1st year, end of 2nd year
Study Arms (2)
The control group
NO INTERVENTIONPatients in the control group would go through observation and follow-up after recurrent endoscopic surgery.
The experimental group
EXPERIMENTALPatients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
- 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;
- Cervical lymph node metastasis can be controlled locally
- Age 18 to 75 years;
- Without distant metastasis;
- Informed consent forms signed;
- ≥6months from the accomplishment of radiation to recurrence
- previously radiotherapy for only 1 course;
- ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
- Sufficient organ function;
- Undergone endoscopic surgery with negative pathological margin;
You may not qualify if:
- Participation in other interventional clinical trials;
- Uncontrolled illnesses which will interfere with the ability to undergo therapy;
- Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
- Any contradiction to immune and chemotherapy;
- With serious autoimmune disease;
- 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;
- Severe allergic reactions to other monoclonal antibodies;
- History of radioactive particle planting;
- Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
- Female patients who are at pregnancy or lactation;
- Other situations that the researchers believe are not suitable for enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eye & ENT Hospital of Fudan Universitylead
- Shanghai Zhongshan Hospitalcollaborator
- Shanghai 6th People's Hospitalcollaborator
- Changhai Hospitalcollaborator
- Fujian Medical University Union Hospitalcollaborator
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- Shenzhen Second People's Hospitalcollaborator
Study Sites (7)
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031, China
Fujian Medical University Union Hospital
Fuzhou, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Changhai Hospital
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Shanghai Zhongshan Hospital
Shanghai, China
Shenzhen Second People's Hospital
Shenzhen, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongmeng Yu
Eye& ENT Hospital, Fudan University
Central Study Contacts
Yuting Lai
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2023
First Posted
January 29, 2024
Study Start
June 25, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
July 4, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR