A Real-world Study of the Efficacy and Safety of PD-1 Inhibitors Combined With Chemoradiotherapy in Lung Metastatic 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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2025-12-31

Brief Summary

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This study is a retrospective real-world study. In this study, we plan to collect the clinical data of lung metastatic nasopharyngeal carcinoma patients who received PD-1 inhibitors and chemotherapy combined with or without radiotherapy.

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Detailed Description

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Conditions

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Lung Metastatic Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Group Type ACTIVE_COMPARATOR

Control: gemcitabine, cisplatin, tirelizumab

Intervention Type DRUG

PD-1 inhibitors combined with chemotherapy

Experimental group

Group Type EXPERIMENTAL

Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy

Intervention Type DRUG

PD-1 inhibitors combined with chemoradiotherapy

Interventions

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Control: gemcitabine, cisplatin, tirelizumab

PD-1 inhibitors combined with chemotherapy

Intervention Type DRUG

Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy

PD-1 inhibitors combined with chemoradiotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. age of at least 18 years;
2. Karnofsky Performance Status (KPS) ≥60;
3. histologically confirmed nasopharyngeal squamous carcinoma;
4. metastatic disease after primary standard treatment (patients who had metastatic diseases over six months after treatment);
5. at least 1 measurable metastatic lesions in lung or mediastinal or pleura (imaging for distant metastases with FDG-PET/CT or chest/abdomen CT with contrast);
6. adequate renal , liver and bone marrow function.

Exclusion Criteria

1. previous treatment with an immune checkpoint inhibitor;
2. recurrent disease;
3. previous systemic chemotherapy for metastatic disease;
4. symptomatic central nervous system metastases;
5. a history of non-infectious pneumonitis that required glucocorticoids, or active autoimmune disease;
6. severe organ dysfunction or not suitable for chemoradiotherapy;
7. individuals that had serious kidney, heart, blood, nervous system, or liver diseases or psychiatric disorders;
8. individuals that had taken part in any other clinical trials testing other drugs within 3 months of the present study;
9. other patients whom researchers deemed unsuitable to participate in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No