Non Small Cell Lung CancerNCT05291403
Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion
A study testing Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer, Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer and Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment in people with Non Small Cell Lung Cancer, run by Qianfoshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer, Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer and Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 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.
Who cannot join
- 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;
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- multiple serous cavity effusion, or bilateral pleural effusion;
- patients allergic to erythromycin;
- the lung cannot be reopened.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
Qian Qi, Doctor, +86 13706380314, qiqianqlh@163.com
About this study
Official title: 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer, Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer, Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment
- Keywords
- advanced Non-small Cell Lung Cancer, Malignant Pleural Effusion, Thoracoscopy, Cryotherapy Effect
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancerOther
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.
Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancerOther
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.
Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (medical thoracoscopic cryotherapy) | Experimental | Not described Receives: 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 | Not described Receives: 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. Receives: Other: Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 months
Secondary outcomes (5)
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.
Measured: up tp 2 months
Progression-free survival (PFS)
Measured: 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.
Measured: up to 2 months
Overall survival time
Measured: up to 2 months
Adverse reactions
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start6 Apr 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291403
- Sponsor's protocol ID
- 2022-2-21-QFS
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05291403
- Acronym / sponsor ID
- 2022-2-21-QFS
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- advanced Non-small Cell Lung Cancer, Malignant Pleural Effusion, Thoracoscopy, Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatmentOnly intrathoracic tube was used to drain pleural effusion, and local pleural cavity was not treated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancerMedical 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. | Other | Experimental group (medical thoracoscopic cryotherapy) |
| Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancerThe 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 | Cisplatin/erythromycin control group (sequential intrathoracic injection of cisplatin/erythromycin) |
| Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatmentOnly 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. | Other | Blank control group |
Primary outcome
pleural progression free survival, P-PFS
Time frame: 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.
5 secondary outcomes
Total effective rate
Time frame: up tp 2 months
Progression-free survival (PFS)
Time frame: up to 2 months
modified Medical Research Council Dyspnea Scale
Time frame: up to 2 months
Overall survival time
Time frame: up to 2 months
Adverse reactions
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer, Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer and Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment in people with Non Small Cell Lung Cancer, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Qi, doctor (8613706380314, qiqianqlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pleural progression free survival, P-PFS (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.