Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial
Eye & ENT Hospital of Fudan University
154 participants
Jul 9, 2024
INTERVENTIONAL
Conditions
Summary
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
Eligibility
Inclusion Criteria10
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
- 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;
- Cervical lymph node metastasis can be controlled locally;
- Aged 18 to 75 years;
- Informed consent forms signed to participate in the trial;
- Without distant metastasis;
- ≥6months from the accomplishment of radical radiation to recurrence
- previously only 1 course of radiotherapy;
- Sufficient organ function;
- ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.
Exclusion Criteria11
- Participate in other interventional clinical trials;
- Uncontrolled illnesses that interfere with the therapy;
- Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
- Any contradiction to surgery;
- With serious autoimmune disease;
- 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;
- 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 not suitable for enrollment
Interventions
The tumor was resected by endoscopic nasopharyngectomy.
Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.
Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.
Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.
Locations(7)
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NCT06235203