Actively Recruiting
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-07-04
176
Participants Needed
7
Research Sites
N/A
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
Researchers are investigating treatments for early-stage recurrent nasopharyngeal carcinoma, a type of cancer that returns in the nasopharynx area. This multicenter, randomized clinical trial compares the effects of adjuvant therapy, including chemotherapy and immunotherapy, with endoscopic surgery alone. The study aims to evaluate disease-free survival and other outcomes in patients with this condition. Participants are randomly assigned to one of two groups. The control group undergoes observation and follow-up after endoscopic surgery, while the experimental group receives adjuvant therapy consisting of four to six cycles of chemotherapy with a gemcitabine-based regimen and up to ten cycles of immunotherapy using Toripalimab Injection. Treatment continues until completion or unacceptable side effects occur. During the study, participants will be closely monitored through regular assessments to measure disease-free survival, overall survival, local recurrence, and distant metastasis rates up to 24 to 60 months. Follow-up includes evaluations of health status and cancer progression. The total participation period may extend up to five years, including safety monitoring and outcome assessments.
CONDITIONS
Brief 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, 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
- Signed informed consent forms
- At least 6 months from completion of radiation to recurrence
- Received only 1 course of radiotherapy previously
- 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 ability to undergo therapy
- Having another or multiple malignancies within 5 years (except fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ)
- Any contraindications to immune or chemotherapy
- Serious autoimmune disease
- Current use of immunosuppressive agents or systemic glucocorticoid therapy (dose >10mg/day prednisone or equivalent), and continued use within 2 weeks before trial drug administration
- Severe allergic reactions to other monoclonal antibodies
- History of radioactive particle implantation
- Vaccination with live vaccine within 4 weeks before or during the study
- Female patients who are pregnant or breastfeeding
- Other situations judged by researchers as unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Not specified
Participants undergo endoscopic surgery for recurrent nasopharyngeal carcinoma followed by initial recovery and monitoring.
1 visit (in-person) for surgery and immediate post-operative care
Duration - Until completion of 4 to 6 chemotherapy cycles and 10 immunotherapy cycles or until unacceptable side effects
Participants in the experimental group receive adjuvant therapy including 4 to 6 cycles of chemotherapy and up to 10 cycles of immunotherapy after surgery. Participants in the control group undergo observation without additional treatment.
Multiple visits for chemotherapy and immunotherapy cycles as scheduled
Duration - Up to 24 months
Participants in the control group are observed and followed up after surgery. The trial monitors all participants for recurrence, metastasis, or death up to 24 months.
Regular follow-up visits up to 24 months
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
Y
Yuting Lai
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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