Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

Eye & ENT Hospital of Fudan University

Status and phase

Enrolling

Phase 2

Conditions

Recurrent Nasopharyngeal Carcinoma

Treatments

Drug: Camrelizumab

Procedure: endoscopic surgery

Drug: Chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05011227

rNPC-SA-Neo-Cam-V1

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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