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Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

Recruiting
18 years of age
Both
Phase 2

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Overview

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

Eligibility

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

Study details

Recurrent Nasopharyngeal Carcinoma

NCT05011227

Eye & ENT Hospital of Fudan University

7 March 2024

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