Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

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

Official Title
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A Prospective, Single-arm, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma

Conditions
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Recurrent Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Camrelizumab
* Drug: Chemotherapy
* Procedure: endoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Camrelizumab and chemotherapy combined with endoscopic surgery<br>Camrelizumab and chemotherapy combined with endoscopic surgery | Drug: Camrelizumab<br>* 2 cycles before endoscopic surgery and one year after<br>Drug: Chemotherapy<br>* 2 cycles before endoscopic surgery, with or without after surgery<br>Procedure: endoscopic surgery<br>* standard endoscopic surgery for recurrent nasopharyngeal carcinoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 2 year Overall Survival rate | From date of first treatment until the date of death from any cause, up to 4 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence free survival | the date of first treatment to local failure or death | From date of first treatment until the date of local recurrence or death from any cause, up to 4 years. | 
| Progression free survival | the date of first treatment to the first recording of disease progression or death from any cause. | From date of first treatment until the date of disease progression or death from any cause, up to 4 years. | 
| Rate of negative margin | negative margin rate according to pathology report | At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years. | 
| distant metastasis free survival | the date of first treatment to distant metastasis or death | From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years. | 
| pathologic complete remission | pathologic complete remission | At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic surgery, Inductive chemotherapy