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

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

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).

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yanqun Xiang, Dr; Phone Number: +86-18666096623; Email: xiangyq@sysucc.org.cn
• Study Contact Backup: Name: Weixiong Xia, Dr; Phone Number: +86-18520415699; Email: xiawx@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Yanqun Xiang
      • Contact: Yanqun Xiang, Dr.; Phone Number: +8618666096623; Email: xiangyq@sysucc.org.cn
      • Contact: Weixiong Xia, Dr.; Phone Number: +8618520415699; Email: xiawx@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Toripalimab; PD-1 Immune Checkpoint Inhibitor Combined With IMRT,used at 2 weeks before radiotherapy, once every 2 weeks, 10 cycles in total; Other Names: Programmed cell death protein 1(PD-1)；Immune checkpoint inhibitors（ICIs); Procedure: Intensity modulated radiotherapy; Intensity modulated radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	Patients in clinical trials were randomized to the time of death from any cause	2 years
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
Distant metastasis-free survival(DMFS)	Patients in clinical trials were randomized to the time of distant metastasis	2 years
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

Collaborators and Investigators

• Sponsor: XIANG YANQUN
• Investigators: Principal Investigator: Yanqun Xiang, Dr, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immune Checkpoint Inhibitors
• Other Study ID Numbers: B2021-292-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No