Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

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

218 Participants
are divided into 2 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