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Efficacy and safety of medical thoracoscopic cryotherapy combined with standard first-line regimen in the treatment of advanced non-small cell lung cancer with malignant pleural effusion: a multicenter, prospective, randomized controlled clinical trial

Efficacy and safety of medical thoracoscopic cryotherapy combined with standard first-line regimen in the treatment of advanced non-small cell lung cancer with malignant pleural effusion: a multicenter, prospective, randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056151
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-02-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Experimental group:Medical thoracoscopy cryotherapy for malignant pleural effusion
Cisplatin/erythromycin control group:Sequential intrapleural infusion of cisplatin/erythromycin
Blank control group:Only the intrapleural tube was used to drain pleural effusion, and the local pleural cavity was not treated.

Sponsors

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Non-small cell lung cancer with pleural metastasis confirmed by histopathology or cytology; 3. ECOG score 0-1 points; 4. Cardiopulmonary function can tolerate painless medical thoracoscopy; 5. Patients who underwent medical thoracoscopy for the initial diagnosis of pleural effusion, underwent medical thoracoscopy cryotherapy at the same time as biopsy, and were confirmed to be non-small cell lung cancer by pathological results were also included in the study; 6. All subjects or their guardians must sign an informed consent form before entering the trial.

Exclusion criteria

Exclusion criteria: 1. Expected survival time 1.5 times the upper limit of normal); 4. Received chemotherapy or anti-angiogenic drug treatment (such as bevacizumab, endor, anlotinib, etc.; 5. History of radiotherapy; 6. History of local treatment in the thoracic cavity; 7. Multiple serous cavity effusion, or bilateral pleural effusion; 8. Patients who are allergic to erythromycin; 9. Those who cannot recruit the lungs.

Design outcomes

Primary

MeasureTime frame
Pleural progression free survival, P-PFS;

Countries

China

Contacts

Public ContactDegan LU

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

deganlu@126.com+86 18753157623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026