Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma

NPC2020-001

This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma

2020-12-30

2026-03-01

2026-03-01

Recruiting

Early phase I

200

Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma 2. Clinical staged as T4 or N3 （according to the 8th AJCC edition） 3. No evidence of distant metastasis (M0) 4. Male and no pregnant female 5. ECOG (Eastern Cooperative OncologyGroup) scale 0-1 6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L 7. Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN) 8. Normal renal function test ( creatinine clearance ≥60 ml/min) Exclusion Criteria: 1. Recurrent or distant metastatic disease. 2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years. 3. History of radiotherapy or chemotherapy. 4. History of immunodeficiency disease 5. History of organ transplantation 6. Presence of life-threatening illness 7. Uncontrolled hypercalcemia 8. Severe uncontrolled medical conditions or active infectious diseases 9. Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks. 10. Pregnant or breastfeeding female 11. Emotional disturbance or mental illness 12. Refusal or inability to sign informed consent

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-05-01