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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-12

Study Completion Date

2023-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Toripalimab

Intervention Type DRUG

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

Intensity modulated radiotherapy

Intervention Type PROCEDURE

Intensity modulated radiotherapy

Interventions

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Toripalimab

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

Intervention Type DRUG

Intensity modulated radiotherapy

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No