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Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

RECRUITINGPhase 2Sponsored by Eye & ENT Hospital of Fudan University
Actively Recruiting
PhasePhase 2
SponsorEye & ENT Hospital of Fudan University
Started2021-08-10
Est. completion2025-08-10
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerRecurrent Nasopharyngeal Carcinoma

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