Adjuvant vs Surgery Only in Early-stage Recurrent NPC

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding an extra treatment called adjuvant therapy can help patients with early-stage recurrent nasopharyngeal carcinoma (NPC) do better compared to just having surgery. The study is looking specifically at patients who have already had surgery and are between the ages of 18 and 70, have been diagnosed with a specific stage of NPC, and have had their cancer come back after radiation treatment. Participants must also be in good overall health and have not had other serious health problems that could interfere with the trial.

If you or a loved one decides to participate, you will undergo careful monitoring and may receive either the adjuvant therapy alongside surgery or just have the surgery alone. The trial is currently recruiting, which means there are still spots available for interested patients. It's important to know that anyone who has participated in another clinical trial recently or has certain health issues may not be eligible. This trial aims to find out which approach is more effective in helping patients with this type of cancer, and your participation could contribute to important medical knowledge.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
• • 2. Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery ≤5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
• • 3. Cervical lymph node metastasis can be controlled locally
• • 4. Age 18 to 75 years;
• • 5. Without distant metastasis;
• • 6. Informed consent forms signed;
• • 7. ≥6months from the accomplishment of radiation to recurrence
• • 8. previously radiotherapy for only 1 course;
• • 9. ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
• • 10. Sufficient organ function;
• • 11. Undergone endoscopic surgery with negative pathological margin;
• Exclusion Criteria:
• • 1. Participation in other interventional clinical trials;
• • 2. Uncontrolled illnesses which will interfere with the ability to undergo therapy;
• • 3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
• • 4. Any contradiction to immune and chemotherapy;
• • 5. With serious autoimmune disease;
• • 6. Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage\>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
• • 7. Severe allergic reactions to other monoclonal antibodies;
• • 8. History of radioactive particle planting;
• • 9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
• • 10. Female patients who are at pregnancy or lactation;
• • 11. Other situations that the researchers believe are not suitable for enrollment