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

Qianfoshan Hospital

Status: Enrolling

Conditions: Non Small Cell Lung Cancer

Treatments: Other: Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment; Other: Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer; Other: Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT05291403

2022-2-21-QFS

Details and patient eligibility

About

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.

Enrollment: 141 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 results of 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 3 patient groups

Experimental group (medical thoracoscopic cryotherapy)

Experimental group

Treatment:

Other: Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer

Cisplatin/erythromycin control group (sequential intrathoracic injection of cisplatin/erythromycin)

Active Comparator group

Treatment:

Other: Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer

Blank control group

Other group

Description:

Only intrathoracic tube was used to drain pleural effusion, and local pleural cavity was not treated.

Treatment:

Other: Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment