Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Apr 27, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with recurrent nasopharyngeal carcinoma (NPC), which is a type of cancer that affects the area behind the nose and above the throat. The study is focused on combining a minimally invasive surgery called transnasal endoscopic surgery with immunotherapy, a treatment that helps the body’s immune system fight cancer. The goal is to see if this combination can effectively manage the cancer and improve outcomes for patients.

To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with recurrent NPC that can be surgically removed. They should also be in good overall health, with no distant spread of the cancer. This means they should not have any other serious health issues that would prevent them from undergoing surgery or participating in the study. Those who join the trial can expect to undergo surgery followed by immunotherapy treatments, and they will be closely monitored by the medical team throughout the study. It's important to note that certain individuals, such as those with severe health conditions or other active cancers, may not qualify for this trial.

Gender

ALL

Eligibility criteria

• 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.