Clinical trial NCT05229315: PD-1 Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
T2-3N0 or T1-2N1
EBV-DNA≤4000 Copy/ml
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 0-1.
* 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

Primary outcomes:
measure: Adverse events
timeFrame: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 2 years
measure: progression-free survival (PFS)
timeFrame: 2 years
measure: Distant metastasis-free survival(DMFS)
timeFrame: 2 years
measure: Response rate (based on RECIST ver1.1)
timeFrame: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Yanqun Xiang
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yanqun Xiang, Dr
role: PRINCIPAL_INVESTIGATOR
References: