PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma (T2-3N0 or T1-2N1 and EBV-DNA≤4000 Copy/ml),A Single-arm, Phase II Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Intensity modulated radiotherapy
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- XIANG YANQUN
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).
Detailed Description
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).The primary end point is safety, the secondary end points are short-term efficacy,overall survival (OS), progression-free survival (PFS),Distant metastasis-free survival(DMFS),adverse effects ,quality of life and immune status assessment.
Investigators
XIANG YANQUN
professor
Sun Yat-sen University
Eligibility 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-
- •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.
Arms & Interventions
PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy
Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total
Intervention: Intensity modulated radiotherapy
PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy
Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total
Intervention: Toripalimab
Outcomes
Primary Outcomes
Adverse events
Time Frame: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
The severity of adverse events will be determined by the investigator based on CTCAE v 5.0
Secondary Outcomes
- overall survival (OS)(2 years)
- progression-free survival (PFS)(2 years)
- Distant metastasis-free survival(DMFS)(2 years)
- Response rate (based on RECIST ver1.1)(Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment)