Lung Metastatic Nasopharyngeal CarcinomaNCT07062484
A Real-world Study of the Efficacy and Safety of PD-1 Inhibitors Combined With Chemoradiotherapy in Lung Metastatic Nasopharyngeal Carcinoma
A study testing Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy in people with Lung Metastatic Nasopharyngeal Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Metastatic Nasopharyngeal Carcinoma
- What is being tested?
- Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
Lu Li, 13882258173, lilu_mm@163.com
About this study
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.
- Conditions
- Lung Metastatic Nasopharyngeal Carcinoma
- Being tested
- Control: gemcitabine, cisplatin, tirelizumab, Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control: gemcitabine, cisplatin, tirelizumabDrug
PD-1 inhibitors combined with chemotherapy
Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapyDrug
PD-1 inhibitors combined with chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Drug: Control: gemcitabine, cisplatin, tirelizumab |
| Experimental group | Experimental | Not described Receives: Drug: Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Metastatic Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yangkun Luo, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062484
- Sponsor's protocol ID
- SCCHEC-02-2022-018
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of the Efficacy and Safety of PD-1 Inhibitors Combined With Chemoradiotherapy in Lung Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07062484
- Acronym / sponsor ID
- SCCHEC-02-2022-018
- Conditions
- Lung Metastatic Nasopharyngeal Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Control: gemcitabine, cisplatin, tirelizumab |
| Experimental group | Experimental | Drug: Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control: gemcitabine, cisplatin, tirelizumabPD-1 inhibitors combined with chemotherapy | Drug | Control Group |
| Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapyPD-1 inhibitors combined with chemoradiotherapy | Drug | Experimental group |
Primary outcome
Objective response rate
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: gemcitabine, cisplatin, tirelizumab and radiotherapy in people with Lung Metastatic Nasopharyngeal Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Li (13882258173, lilu_mm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.