Search / Trial NCT06235203

Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Jan 23, 2024

Apply for Trial

Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Description

Eligible patients are randomized into the control group and the experimental group. Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy. Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
  • 2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
  • 3. Cervical lymph node metastasis can be controlled locally;
  • 4. Aged 18 to 70 years;
  • 5. Informed consent forms signed to participate in the trial;
  • 6. Without distant metastasis;
  • 7. ≥6months from the accomplishment of radical radiation to recurrence
  • 8. previously only 1 course of radiotherapy;
  • 9. Sufficient organ function;
  • 10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.
  • Exclusion Criteria:
  • 1. Participate in other interventional clinical trials;
  • 2. Uncontrolled illnesses that interfere with the 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, etc.);
  • 4. Any contradiction to surgery;
  • 5. With serious autoimmune disease;
  • 6. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;
  • 7. Severe allergic reactions to other monoclonal antibodies;
  • 8. Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway);
  • 9. History of radioactive particle planting;
  • 10. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
  • 11. Female patients who are at pregnancy or lactation;
  • 12. Other situations that the researchers believe not suitable for enrollment

About Eye & Ent Hospital Of Fudan University

The Eye & ENT Hospital of Fudan University is a leading clinical research institution dedicated to advancing the fields of ophthalmology and otolaryngology. With a commitment to innovative medical practices and patient-centered care, the hospital integrates cutting-edge research with clinical expertise to conduct comprehensive clinical trials. Leveraging a multidisciplinary approach, the institution aims to enhance treatment modalities and improve patient outcomes through rigorous scientific investigation and collaboration with academic and industry partners. Its state-of-the-art facilities and experienced team of professionals position the Eye & ENT Hospital of Fudan University as a pivotal contributor to medical advancements in eye and ear, nose, and throat health.

Locations

Shanghai, , China

Fuzhou, Fujian, China

Shanghai, , China

Shanghai, , China

Nanning, , China

Shenzhen, , China

Shanghai, Shanghai, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0