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

Not Applicable

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: 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; Other: Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment

• Registration Number: NCT05291403
• Lead Sponsor: Qianfoshan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-03-12
• Study First Posted: 2022-03-22
• Study Start: 2022-04-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 141

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (medical thoracoscopic cryotherapy)	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)	Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer	-
Blank control group	Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment	Only intrathoracic tube was used to drain pleural effusion, and local pleural cavity was not treated.

Primary Outcome Measures

Name	Time	Method
pleural progression free survival, P-PFS	up to 2 months	According to Millar's criteria, P-PFS was defined as absence of pleural effusion lasting more than 4 weeks; Or an order of magnitude reduction in pleural effusion (such as large to medium volume, or medium to small volume) lasting more than 4 weeks; Or pleural effusion with no significant change, lasting more than 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to 2 months
modified Medical Research Council Dyspnea Scale	up to 2 months	The modified Medical Research Council Dyspnea Scale (mMRC) is used to assess degree of baseline functional disability due to dyspnea. The minimum and maximum values are 0 and 4, and higher scores mean a worse outcome. Score 0 means dyspnea only with strenuous exercise; score 1 means dyspnea when hurrying or walking up a slight hill; score 2 means walks slower than people of the same age because of dyspnea or has to stop for breath when walking at own pace; score 3 means stops for breath after walking 100 yards (91 m) or after a few minutes; score 4 means too dyspneic to leave house or breathless when dressing.
Total effective rate	up tp 2 months	Complete remission (CR) : pleural effusion disappeared and lasted for more than 4 weeks; Partial remission (PR) : reduction of pleural effusion by 1 order of magnitude (e.g., large to medium volume, or medium to small volume) for more than 4 weeks; CR+PR was denoted as the total effective rate.
Overall survival time	up to 2 months
Adverse reactions	up to 2 months

Trial Locations

Locations (1)

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China