PD-1 Combined With IMRT in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with IMRT in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XIANG YANQUN

Criteria

Inclusion Criteria:

• Newly diagnosed patients who have not received radiotherapy or chemotherapy

• Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, WHO classification type II or type III).

• T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml (AJCC 8th version) and EBV-DNA≤4000copies/ml

• Male or non-pregnant female

• Age between 18 and 65

• Eastern Cooperative Oncology Group（ECOG）score of 0-1.

• Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.

• Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <2.0 times the upper limit of normal (ULN); total bilirubin <2.0×ULN.

• Renal function: creatinine clearance rate ≥60ml/min or serum creatinine <1.5×ULN.

• The patient has signed the informed consent

Exclusion Criteria:

• The pathology is keratinizing squamous cell carcinoma (WHO classification is type I).

• Patients with recurrence and distant metastasis.

• Patients who have undergone radiotherapy or chemotherapy.

• Active hepatitis B (HBV-DNA≥500).

• Patients with autoimmune diseases.

• Patients with HIV infection.

• At the same time suffering from other uncontrolled serious diseases.

• Persons with abnormal functions of the heart, brain, lungs and other important organs.

• Age> 65 years.

• pregnancy or breast feeding.

• Persons with personality or mental illness, without or with limited capacity for civil conduct