Status:
UNKNOWN
PD-1 Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma
Lead Sponsor:
XIANG YANQUN
Conditions:
Nasopharyngeal Carcinoma
T2-3N0 or T1-2N1
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05229315
Start Date
March 12 2022
End Date
December 1 2023
Last Update
April 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yanqun Xiang
Guangzhou, Guangdong, China, 510000