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
Yangkun Luo
Director
Sichuan Cancer Hospital and Research Institute
Study Sites (1)
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