Adjuvant vs Surgery Only in Early-stage Recurrent NPC
Recruiting now · Phase 3
Conditions studied: Recurrent Nasopharyngeal Carcinoma
In brief
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Key facts
- Study ID
- NCT06228079
- Run by
- Eye & ENT Hospital of Fudan University
- People needed
- 176
- Starts
- 2024-06-25
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-07-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Changhai Hospital — Shanghai, China (enrolling)
- The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, China (enrolling)
- Eye& ENT Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
- Shenzhen Second People's Hospital — Shenzhen, China
- Shanghai Sixth People's Hospital — Shanghai, China
- Fujian Medical University Union Hospital — Fuzhou, China
- Shanghai Zhongshan Hospital — Shanghai, China
Full record on ClinicalTrials.gov
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