🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06228079
Recruiting Phase 3

Adjuvant vs Surgery Only in Early-stage Recurrent NPC

NCT06228079 · tracked via the Priya Life Science China tracker
Sponsor
Eye & ENT Hospital of Fudan University
Phase
Phase 3
Started
2024-06-25
Last updated
2025-07-04

Condition(s) studied

Recurrent Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

Immunotherapy,Toripalimab InjectionChemotherapy,Gemcitabine based regimen

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.

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Eye& ENT Hospital, Fudan University Shanghai Shanghai Municipality Recruiting
Fujian Medical University Union Hospital Fuzhou China Not Yet Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region Nanning China Recruiting
Changhai Hospital Shanghai China Recruiting
Shanghai Sixth People's Hospital Shanghai China Not Yet Recruiting
Shanghai Zhongshan Hospital Shanghai China Not Yet Recruiting
Shenzhen Second People's Hospital Shenzhen China Not Yet Recruiting

More Eye & ENT Hospital of Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06228079 on ClinicalTrials.gov ↗ ← All trials in China