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Clinical Trials/NCT07062484
NCT07062484Not yet recruitingNot Applicable

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

Sichuan Cancer Hospital and Research Institute1 site in 1 country600 target enrollmentStarted: July 1, 2025Last updated:
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
600
Locations
1
Primary Endpoint
Objective response rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age of at least 18 years;
  • Karnofsky Performance Status (KPS) ≥60;
  • histologically confirmed nasopharyngeal squamous carcinoma;
  • metastatic disease after primary standard treatment (patients who had metastatic diseases over six months after treatment);
  • 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);
  • adequate renal , liver and bone marrow function.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Objective response rate

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sichuan Cancer Hospital and Research Institute
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yangkun Luo

Director

Sichuan Cancer Hospital and Research Institute

Study Sites (1)

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