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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangxi Provincial Cancer Hospital
• Treatments: Antibodies; Cisplatin; Gemcitabine

Criteria

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