Adjuvant vs Surgery Only in Early-stage Recurrent NPC
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Eye & ENT Hospital of Fudan University
176 participants
Jun 25, 2024
INTERVENTIONAL
Conditions
Summary
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Eligibility
Inclusion Criteria11
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
- 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;
- Cervical lymph node metastasis can be controlled locally
- Age 18 to 75 years;
- Without distant metastasis;
- Informed consent forms signed;
- ≥6months from the accomplishment of radiation to recurrence
- previously radiotherapy for only 1 course;
- ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
- Sufficient organ function;
- Undergone endoscopic surgery with negative pathological margin;
Exclusion Criteria11
- Participation in other interventional clinical trials;
- Uncontrolled illnesses which will interfere with the ability to undergo therapy;
- Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
- Any contradiction to immune and chemotherapy;
- With serious autoimmune disease;
- 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;
- Severe allergic reactions to other monoclonal antibodies;
- History of radioactive particle planting;
- Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
- Female patients who are at pregnancy or lactation;
- Other situations that the researchers believe are not suitable for enrollment
Interventions
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Locations(7)
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NCT06228079