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

Phase 2

Recruiting

• Conditions: Nasopharyngeal Carcinoma; T2-3N0 or T1-2N1; EBV-DNA≤4000 Copy/ml
• Interventions: Drug: Toripalimab; Procedure: Intensity modulated radiotherapy

• Registration Number: NCT05229315
• Lead Sponsor: XIANG YANQUN

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.

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-08
• Study Start: 2022-03-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy	Intensity modulated radiotherapy	Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total
PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy	Toripalimab	Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total

Primary Outcome Measures

Name	Time	Method
Adverse events	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 Outcome Measures

Name	Time	Method
overall survival (OS)	2 years	Patients in clinical trials were randomized to the time of death from any cause
progression-free survival (PFS)	2 years	The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause
Distant metastasis-free survival(DMFS)	2 years	Patients in clinical trials were randomized to the time of distant metastasis
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	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

Trial Locations

Locations (1)

Yanqun Xiang; 🇨🇳 Guangzhou, Guangdong, China