Adjuvant vs Surgery Only in Early-stage Recurrent NPC
ConditionRecurrent Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEye & ENT Hospital of Fudan University
About this trial
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Immunotherapy,Toripalimab Injection
- Chemotherapy,Gemcitabine based regimen
Treatment groups
176 Participants
are divided into 2 treatment groupsSponsors and collaborators
Eye & ENT Hospital of Fudan University
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Shanghai 6th People's Hospital
Collaborator
Changhai Hospital
Collaborator
Fujian Medical University Union Hospital
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Shenzhen Second People's Hospital
Collaborator
Source ClinicalTrials.gov