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

NCT ID: NCT05291403

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2024-12-31

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group (medical thoracoscopic cryotherapy)

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Medical thoracoscopic cryotherapy: medical thoracoscopy biopsy hole insert bendable freezing probes, place the frozen probe placed in the center of the tumor at the top will be frozen carbon dioxide gas source pressure adjustment to the bar of 50-60 bar, tread down switch, foot pedal to start the probe, after about 30 s at the top of the probe to form a ice hockey, local tissue after frozen white, sometimes a small amount of bleeding; Fix the probe, loosen the pedal, and wait 30 seconds for automatic melting and rewarming (bleeding probability is low after full rewarming). Freeze 5 to 10 at a time.

In addition, all patients were treated with standard first-line regimens according to guidelines of non small cell lung cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG) scores.

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

The pleural effusion was fully drained and cisplatin 40mg/m2 was given, dissolved in 100mL 0.9% sodium chloride (NaCl) solution 100 mL, then injected into the pleural cavity and retained for 24 hours. Erythromycin was sequentially injected into the thorax to seal the pleural cavity.

In addition, all patients were treated with standard first-line regimens according to guidelines of NSCLC and ECOG scores.

Blank control group

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

Group Type: OTHER

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

Intervention Type: OTHER

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

In addition, all patients were treated with standard first-line regimens according to guidelines of NSCLC and ECOG scores.

Interventions

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

Medical thoracoscopic cryotherapy: medical thoracoscopy biopsy hole insert bendable freezing probes, place the frozen probe placed in the center of the tumor at the top will be frozen carbon dioxide gas source pressure adjustment to the bar of 50-60 bar, tread down switch, foot pedal to start the probe, after about 30 s at the top of the probe to form a ice hockey, local tissue after frozen white, sometimes a small amount of bleeding; Fix the probe, loosen the pedal, and wait 30 seconds for automatic melting and rewarming (bleeding probability is low after full rewarming). Freeze 5 to 10 at a time.

In addition, all patients were treated with standard first-line regimens according to guidelines of non small cell lung cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG) scores.

Intervention Type: OTHER

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

The pleural effusion was fully drained and cisplatin 40mg/m2 was given, dissolved in 100mL 0.9% sodium chloride (NaCl) solution 100 mL, then injected into the pleural cavity and retained for 24 hours. Erythromycin was sequentially injected into the thorax to seal the pleural cavity.

In addition, all patients were treated with standard first-line regimens according to guidelines of NSCLC and ECOG scores.

Intervention Type: OTHER

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.

In addition, all patients were treated with standard first-line regimens according to guidelines of NSCLC and ECOG scores.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qian Qi

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qian Qi, doctor

Role: CONTACT

qiqianqlh@163.com

8613706380314

Facility Contacts

Qian Qi, Doctor

Role: primary

qiqianqlh@163.com

+86 13706380314

Other Identifiers

2022-2-21-QFS

Identifier Type: -

Identifier Source: org_study_id