Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2025-08-10
• Target enrollment: 0
• Participant gender: All

Summary

To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eye & ENT Hospital of Fudan University
• Collaborator: Chinese Academy of Medical Sciences

Criteria

Inclusion Criteria:

• Pathologically confirmed recurrent nasopharyngeal carcinoma

• American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent T4 which can be surgically removed

• Age ≥18 years old

• Informed consent signed

• With or without lymph node metastasis, which can be surgically removed

• No massive hemorrhage risk recently

• No distant metastasis

• ≥6 months from initial radiotherapy to recurrence

• Radical radiation only once

• Sufficient organ function

• Eastern Cooperative Oncology Group score 0-2

Exclusion Criteria:

• With a history of allergic to platinum drugs and similar compounds

• Evidence of distant metastasis or radiation encephalopathy or leptomeningeal disease (LMD)

• Have received radioactive seed implantation in the treatment area

• Suffer from uncontrolled disease which could interfere with treatment

• Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.)

• The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on

• The patients have autoimmune diseases

• The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration

• Severe allergic reaction to other monoclonal antibodies

• Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment

• Live vaccines have been inoculated within 4 weeks before the first administration or during the study period

• The patient has any situation that may hinder study compliance or the safety during the study period

• Existence of serious neurological or psychiatric diseases, such as dementia and seizures

• Uncontrolled active infection

• Pregnant or breastfeeding women

• Those who have no personal freedom and independent capacity for civil conduct

• There are other situations that are not suitable for entry into the study