Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion

Last updated: March 20, 2023
Sponsor: Qianfoshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pleural Effusion

Lung Disease

Treatment

N/A

Clinical Study ID

NCT05291403
2022-2-21-QFS
  • Ages 18-75
  • All Genders

Study Summary

This study intends to investigate the efficacy and safety of medical thoracoscopic cryotherapy combined with standard first-line treatment of advanced non-small cell lung cancer with malignant pleural effusion through a randomized controlled clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18-75 years old;
  2. Non-small cell lung cancer with pleural metastasis confirmed by histopathology orcytology;
  3. ECOG score 0-1;
  4. Cardiopulmonary function can tolerate painless thoracoscopic examination;
  5. Patients who underwent medical thoracoscopy for pleural effusion at first diagnosisand underwent medical thoracoscopy cryotherapy at the same time of biopsy were alsoincluded in the study. Non-small cell lung cancer was confirmed by pathologicalresults;
  6. All subjects or their guardians must sign the informed consent before entering thestudy.

Exclusion

Exclusion Criteria:

  1. Expected survival <2 months;
  2. Hemoglobin <110g/L, white blood cell count <3×109/L, neutrophil <2.0×109/L, platelet <100×109/L;
  3. severe cardiac insufficiency, abnormal liver and kidney function (blood test resultsof transaminase and creatinine > 1.5 times the normal upper limit);
  4. have received chemotherapy or anti-angiogenic drugs (such as bevacizumab, endu,anlotinib, etc.);
  5. History of radiotherapy;
  6. history of intrathoracic local treatment;
  7. multiple serous cavity effusion, or bilateral pleural effusion;
  8. patients allergic to erythromycin;
  9. the lung cannot be reopened.

Study Design

Total Participants: 141
Study Start date:
April 06, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong 250014
    China

    Active - Recruiting

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