Actively Recruiting
Adjuvant vs Surgery Only in Early-stage Recurrent NPC
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-07-04
176
Participants Needed
7
Research Sites
209 weeks
Total Duration
On this page
Sponsors
E
Eye & ENT Hospital of Fudan University
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
CONDITIONS
Official Title
Adjuvant vs Surgery Only in Early-stage Recurrent NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma
- Stage rT1, rT2 (superficial parapharyngeal space, >5mm from internal carotid artery), or rT3 (confined to bottom wall of sphenoid sinus) according to AJCC 8th edition
- Cervical lymph node metastasis can be controlled locally
- Age 18 to 75 years
- No distant metastasis
- Signed informed consent forms
- At least 6 months since completing radiation therapy before recurrence
- Only one previous radiotherapy course
- ECOG score 0-2 and able to tolerate chemotherapy and immunotherapy
- Sufficient organ function
- Undergone endoscopic surgery with negative pathological margin
You will not qualify if you...
- Participation in other interventional clinical trials
- Uncontrolled illnesses interfering with therapy
- Another or multiple malignancies within 5 years (except fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ)
- Contraindications to immune therapy or chemotherapy
- Serious autoimmune disease
- Current use of immunosuppressive agents or systemic glucocorticoids (>10mg/day prednisone or equivalent), continuing within 2 weeks before trial drug
- Severe allergic reactions to other monoclonal antibodies
- History of radioactive particle implantation
- Vaccination with live vaccine within 4 weeks before or during the study
- Pregnancy or lactation in female patients
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
2
Fujian Medical University Union Hospital
Fuzhou, China
Not Yet Recruiting
3
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Actively Recruiting
4
Changhai Hospital
Shanghai, China
Actively Recruiting
5
Shanghai Sixth People's Hospital
Shanghai, China
Not Yet Recruiting
6
Shanghai Zhongshan Hospital
Shanghai, China
Not Yet Recruiting
7
Shenzhen Second People's Hospital
Shenzhen, China
Not Yet Recruiting
Research Team
X
Xiaole Song, MD
CONTACT
Y
Yuting Lai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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