Neoadjuvant vs Adjuvant in Locally Advanced 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
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
Eligibility criteria
Qualifiers
Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
Cervical lymph node metastasis can be controlled locally;
Aged 18 to 75 years;
Disqualifiers
Participate in other interventional clinical trials;
Uncontrolled illnesses that interfere with the therapy;
Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
Any contradiction to surgery;
Trial design
Treatments tested in this trial
- endoscopic surgery
- Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy
- Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy
- Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy
Treatment groups
154 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