Not yet recruiting NCT07062484
A Real-world Study of the Efficacy and Safety of PD-1 Inhibitors Combined With Chemoradiotherapy in Lung Metastatic Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control: gemcitabine, cisplatin, tirelizumab, Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy.
- Who it may be relevant to
- Registry conditions: Lung Metastatic Nasopharyngeal Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Control: gemcitabine, cisplatin, tirelizumab
PD-1 inhibitors combined with chemotherapy - Drug Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy
PD-1 inhibitors combined with chemoradiotherapy
Primary outcome measures
- Objective response rate [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sichuan Cancer Hospital and Research Institute — Chengdu
Identifiers
NCT: NCT07062484 · SCCHEC-02-2022-018