Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Aug 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with recurrent nasopharyngeal carcinoma, a type of cancer that comes back after initial treatment. The researchers want to see how well Camrelizumab, a type of immunotherapy, works when combined with chemotherapy and endoscopic surgery. The goal is to find out if this combination can help patients with this challenging condition.

To participate in the trial, you need to be at least 18 years old and have a confirmed diagnosis of recurrent nasopharyngeal carcinoma that can be surgically removed. You should not have any distant spread of the cancer, and you must have had enough time since your last radiation treatment. It's important to sign an informed consent form, which means you'll understand the study and agree to take part. If you join the trial, you can expect to receive a combination of treatments and be closely monitored by the medical team for your safety and progress.

Gender

ALL

Eligibility criteria

• 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