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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07062484

Enrollment

600

Registered

2025-07-14

Start date

2025-07-31

Completion date

2025-12-31

Last updated

2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Metastatic Nasopharyngeal Carcinoma

Brief summary

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.

Interventions

DRUGControl: gemcitabine, cisplatin, tirelizumab

PD-1 inhibitors combined with chemotherapy

DRUGExperimental: gemcitabine, cisplatin, tirelizumab and radiotherapy

PD-1 inhibitors combined with chemoradiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Objective response rate	3 months

Countries

China

Contacts

Primary ContactLu Li

lilu_mm@163.com13882258173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026