PD-1 Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229315
• Other study ID #: B2021-292-01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 12, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Yanqun Xiang, Dr
• Phone: +86-18666096623
• Email: xiangyq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Toripalimab
PD-1 Immune Checkpoint Inhibitor Combined With IMRT,used at 2 weeks before radiotherapy, once every 2 weeks, 10 cycles in total

Procedure:
• Intensity modulated radiotherapy
Intensity modulated radiotherapy

Locations

Country	Name	City	State
China	Yanqun Xiang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
XIANG YANQUN

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	The severity of adverse events will be determined by the investigator based on CTCAE v 5.0	Recent evaluation: 3 months after the end of treatment;Long-term follow-up: 1~5 years after the end of treatment
Secondary	overall survival (OS)	Patients in clinical trials were randomized to the time of death from any cause	2 years
Secondary	progression-free survival (PFS)	The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause	2 years
Secondary	Distant metastasis-free survival(DMFS)	Patients in clinical trials were randomized to the time of distant metastasis	2 years
Secondary	Response rate (based on RECIST ver1.1)	According to the remission assessment criteria of solid tumors,divided into CR, PR, SD, PD.; CR(complete response) All target lesions disappeared and no new lesions appeared PR ( partial response) reduction of the sum of the largest diameters of target lesions by =30%) SD(stable disease)the sum of the largest diameters of target lesions does not shrink to PR, or increases to PD PD(progressive disease) The sum of the largest diameters of target lesions increases by at least 20%, or new lesions appear	Recent evaluation: 3 months after the end of treatment;Long-term follow-up: 1~5 years after the end of treatment