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

The Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined With Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion: a Multicenter, Prospective, Randomized, Controlled Clinical Trial

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 141
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Qi, doctor; Phone Number: 8613706380314; Email: qiqianqlh@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
      • Contact: Qian Qi, Doctor; Phone Number: +86 13706380314; Email: qiqianqlh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group (medical thoracoscopic cryotherapy)	Other: 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.
Active Comparator: Cisplatin/erythromycin control group (sequential intrathoracic injection of cisplatin/erythromycin)	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.
Other: Blank control group; Only intrathoracic tube was used to drain pleural effusion, and local pleural cavity was not treated.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pleural progression free survival, P-PFS	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.	up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total effective rate	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.	up tp 2 months
Progression-free survival (PFS)		up to 2 months
modified Medical Research Council Dyspnea Scale	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.	up to 2 months
Overall survival time		up to 2 months
Adverse reactions		up to 2 months

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 12, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Thoracoscopy; Malignant Pleural Effusion; advanced Non-small Cell Lung Cancer; Cryotherapy Effect
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
• Other Study ID Numbers: 2022-2-21-QFS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No