About this trial
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
Eligibility criteria
Qualifiers
The recurrence time is more than 6 months from the end of radiotherapy.
Histologically confirmed recurrent nasopharyngeal carcinoma.
Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)
Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)
Disqualifiers
Karnofsky Performance Status (KPS) ≤70.
Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
Has known subjects with other malignant tumors.
Has participated in other drug trials within 3 months of planned start of study treatment.
Trial design
Treatments tested in this trial
- Toripalimab
- salvage surgery
Treatment groups
Sponsors and collaborators
Sun Yat-sen University
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
First People's Hospital of Foshan
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Tenth Affiliated Hospital, Sun Yat-sen University
Collaborator