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

Not Applicable

Not yet recruiting

• Conditions: Lung Metastatic Nasopharyngeal Carcinoma

• Registration Number: NCT07062484
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective response rate	3 months

Trial Locations

Locations (1)

Sichuan Cancer Hospital and Research Institute; 🇨🇳 Chengdu, Sichuan, China