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

July 10, 2025 updated by: Yangkun Luo, Sichuan Cancer Hospital and Research Institute
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan Cancer Hospital and Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Drug: Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy
PD-1 inhibitors combined with chemoradiotherapy
Active Comparator: Control Group
Drug: Control: gemcitabine, cisplatin, tirelizumab
PD-1 inhibitors combined with chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Cancer Hospital and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 14, 2025

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCHEC-02-2022-018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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