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NCT Number: NCT07062484

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control: gemcitabine, cisplatin, tirelizumab

Drug

PD-1 inhibitors combined with chemotherapy

Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy

Drug

PD-1 inhibitors combined with chemoradiotherapy

Primary outcomes

  1. Objective response rate

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.