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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Cancer Hospital and Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

previous treatment with an immune checkpoint inhibitor;

recurrent disease;

previous systemic chemotherapy for metastatic disease;

symptomatic central nervous system metastases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control: gemcitabine, cisplatin, tirelizumab

    Drug

    PD-1 inhibitors combined with chemotherapy

  • Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy

    Drug

    PD-1 inhibitors combined with chemoradiotherapy

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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