Overview

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