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

Primary Purpose

Nasopharyngeal Carcinoma, T2-3N0 or T1-2N1, EBV-DNA≤4000 Copy/ml

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Toripalimab

Intensity modulated radiotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yanqun XiangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy

Arm Description

Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total

Outcomes

Primary Outcome Measures

Adverse events

The severity of adverse events will be determined by the investigator based on CTCAE v 5.0

Secondary Outcome Measures

overall survival (OS)

Patients in clinical trials were randomized to the time of death from any cause

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

Distant metastasis-free survival(DMFS)

Patients in clinical trials were randomized to the time of distant metastasis

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

Full Information

NCT ID

NCT05229315

First Posted

January 25, 2022

Last Updated

April 11, 2023

Sponsor

XIANG YANQUN

1. Study Identification

Unique Protocol Identification Number

NCT05229315

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 12, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

XIANG YANQUN

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, T2-3N0 or T1-2N1, EBV-DNA≤4000 Copy/ml

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy

Arm Type

Experimental

Arm Description

Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Other Intervention Name(s)

Programmed cell death protein 1(PD-1)；Immune checkpoint inhibitors（ICIs)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Intensity modulated radiotherapy

Intervention Description

Intensity modulated radiotherapy

Primary Outcome Measure Information:

Title

Adverse events

Description

The severity of adverse events will be determined by the investigator based on CTCAE v 5.0

Time Frame

Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment

Secondary Outcome Measure Information:

Title

overall survival (OS)

Description

Patients in clinical trials were randomized to the time of death from any cause

Time Frame

2 years

Title

progression-free survival (PFS)

Description

The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause

Time Frame

2 years

Title

Distant metastasis-free survival(DMFS)

Description

Patients in clinical trials were randomized to the time of distant metastasis

Time Frame

2 years

Title

Response rate (based on RECIST ver1.1)

Description

Time Frame

Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanqun Xiang, Dr

Phone

+86-18666096623

xiangyq@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Weixiong Xia, Dr

Phone

+86-18520415699

xiawx@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanqun Xiang, Dr

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yanqun Xiang

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanqun Xiang, Dr.

Phone

+8618666096623

xiangyq@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Weixiong Xia, Dr.

Phone

+8618520415699

xiawx@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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