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

NCT05291403 | Unknown

• 1 other identifier: 2022-2-21-QFS
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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

Keywords

advanced Non-small Cell Lung Cancer; Malignant Pleural Effusion; Thoracoscopy; Cryotherapy Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total effective rate

  up tp 2 months

• Progression-free survival (PFS)

  up to 2 months

• modified Medical Research Council Dyspnea Scale

  up to 2 months

• Overall survival time

  up to 2 months

• Adverse reactions

  up to 2 months

Study Arms (3)

Experimental group (medical thoracoscopic cryotherapy)

EXPERIMENTAL

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

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

Blank control group

OTHER

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

Interventions

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

Experimental group (medical thoracoscopic cryotherapy)

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

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

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

Blank control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• Non-small cell lung cancer with pleural metastasis confirmed by histopathology or cytology;
• ECOG score 0-1;
• Cardiopulmonary function can tolerate painless thoracoscopic examination;
• 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;
• All subjects or their guardians must sign the informed consent before entering the study.

You may not qualify if:

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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pleural Neoplasms; Pleural Effusion; Pleural Diseases

Central Study Contacts

Qian Qi, doctor

CONTACT

8613706380314; qiqianqlh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 22, 2022
• Study Start: April 6, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)