Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC

  • End date
    May 8, 2026
  • participants needed
  • sponsor
    Eye & ENT Hospital of Fudan University
Updated on 29 May 2022


A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma

Condition Recurrent Nasopharyngeal Carcinoma
Treatment endoscopic surgery
Clinical Study IdentifierNCT05350891
SponsorEye & ENT Hospital of Fudan University
Last Modified on29 May 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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