Recurrent Nasopharyngeal Carcinoma
Conditions
Brief summary
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
Interventions
PROCEDUREendoscopic surgery
endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy
Sponsors
Chinese Academy of Medical Sciences
Eye & ENT Hospital of Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathology or radiography confirmed recurrent nasopharyngeal carcinoma. * AJCC rT1-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 distant metastasis. * ≥6 months from the end of initial radiotherapy to recurrence. * Sufficient organ function a)Hematology: white blood cells ≥3.0 x 109/L, absolute neutrophil count ≥1.5x 109/L, hemoglobin ≥80 g/L, platelets ≥100 x 109/L. b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times the ULN c) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN. d) Renal function: serum creatinine ≤ 1.5 times ULN. * ECOG score 0-2. general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy.
Exclusion criteria
* Evidence of distant metastasis or leptomeningel 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 2 years. | 2 year progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of enrollment until the date of death from any cause,through study completion,up to 2 years. | 2 year Overall Survival rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Local progression free survival | From date of enrollment to local failure or date of death from any cause,through study completion,up to 2 years. | 2 year Local progression free survival |
| Distant metastasis free survival | From date of enrollment to distant metastasis or date of death from any cause, through study completion,up to 2 years. | 2 year distant metastasis free survival |
| Toxicities | From date of enrollment through study completion,up to 2 years. | Using CTCAE Version5.0 to evaluate incidence of Treatment-Related Adverse Events including treatment related adverse effect and immune related adverse effect. |
Countries
China
Contacts
Primary ContactXiaole Song, MD
Outcome results
None listed