Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial
1 other identifier
interventional
154
1 country
7
Brief Summary
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
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 Jul 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 31, 2024
CompletedStudy Start
First participant enrolled
July 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
June 3, 2025
May 1, 2025
3 years
December 21, 2023
May 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
EFS
Event free survival
From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year
Secondary Outcomes (10)
OS
Time interval of randomization and death of any cause, up to 5 years
DFS
From randomization to recurrence, metastasis or death, up to 1 year
LRFS
From randomization to local recurrence or death, up to 1 year
DMFS
From randomization to distant metastasis or death, up to 1 year
pCR
Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery
- +5 more secondary outcomes
Study Arms (2)
The control group
ACTIVE COMPARATOREndoscopic surgery + adjuvant therapy
The experimental group
EXPERIMENTALNeoadjuvant therapy +endoscopic surgery + adjuvant therapy
Interventions
The tumor was resected by endoscopic nasopharyngectomy.
Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.
Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.
Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.
Eligibility Criteria
You may qualify if:
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
- Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
- Cervical lymph node metastasis can be controlled locally;
- Aged 18 to 75 years;
- Informed consent forms signed to participate in the trial;
- Without distant metastasis;
- ≥6months from the accomplishment of radical radiation to recurrence
- previously only 1 course of radiotherapy;
- Sufficient organ function;
- ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.
You may not qualify if:
- Participate in other interventional clinical trials;
- Uncontrolled illnesses that interfere with the therapy;
- Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
- Any contradiction to surgery;
- With serious autoimmune disease;
- The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;
- 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 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)
Central Study Contacts
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 31, 2024
Study Start
July 9, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR