Lung CancerNCT05807022
Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation
A study testing Percutaneous or transbronchial argon-helium cryoablation in people with Lung Cancer, run by China-Japan Friendship Hospital.
Trial summary
The goal clinical trial is to evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation in primary lung cancer and metastatic lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Percutaneous or transbronchial argon-helium cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or metastatic lung cancer with definite pathological diagnosis
- Not suitable for thoracotomy due to serious or serious lung or systemic diseases
- Peripheral lung cancer involves pleura and chest wall, and cannot be completely removed after surgery
- There are indications for surgical resection, but the patient refuses to operate
- Single tumor, maximum diameter ≤ 5cm
- Or the number of tumors ≤ 3 and the maximum diameter ≤ 3cm
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- ECOG-PS score ≤ 2
- The expected survival period is more than three months
- Those who have not participated in other clinical verifications within 3 months
- Subjects voluntarily signed the informed consent form
Who cannot join
- Serious cardio-cerebral disease or other mental diseases
- Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis
- Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder and multiple pulmonary bullae
- Have a history of immunodeficiency, including HIV test (enzyme-linked immunosorbent assay and Western blotting) positive
- Chemotherapy, radiotherapy, interventional therapy, ablation and surgical treatment within 30 days before surgical treatment
- There is a tendency to severe bleeding, and the platelet is less than 50 × 109/L and severe disorder of coagulation function
Show all 14Show fewer
- Coagulation index (PT, TT, APTT)>2.5 times of the upper normal limit
- Malignant pleural effusion on the same side of the ablation focus was not well controlled
- Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorder
- Those who have extensive extrapulmonary metastasis and are not suitable for ablation treatment
- Those who often use sedatives, sleeping pills, tranquilizers or other addictive drugs
- Pregnant or lactating women
- Those who can not judge the curative effect
- Other conditions determined by the researcher to be unsuitable for the group, such as inability to tolerate cryoablation, difficulty in follow-up, and other serious diseases
Trial locations and contacts
No sites are listed yet.
About this study
The goal clinical trial is to evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation in primary lung cancer and metastatic lung cancer. The main question it aims to answer are:Evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation.
Participants will undergo percutaneous or transbronchial argon-helium cryoablation.
- Conditions
- Lung Cancer
- Being tested
- Percutaneous or transbronchial argon-helium cryoablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous or transbronchial argon-helium cryoablationProcedure or surgery
The participants would undergo Percutaneous or transbronchial argon-helium cryoablation.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous or transbronchial argon-helium cryoablation | Experimental | Not described Receives: Procedure: Percutaneous or transbronchial argon-helium cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate and effective rate of target lesions
Enhanced imaging examination (CT, MRI or color Doppler ultrasound)
Measured: during the operation of argon-helium cryoablation
Complete response rate and effective rate of target lesions
Enhanced imaging examination (CT, MRI or color Doppler ultrasound)
Measured: 1 week after the operation of argon-helium cryoablation
Complete response rate and effective rate of target lesions
Enhanced imaging examination (CT, MRI or color Doppler ultrasound)
Measured: 4 weeks(±7d) after the operation of argon-helium cryoablation
Secondary outcomes (4)
the iceball coverage rate during the procedure
CT
Measured: during the procedure
Subjects' tolerance of the procedure
questionnaire
Measured: 1 week after the operation of argon-helium cryoablation
the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score
ECOG-PS questionnaire
Measured: 4 weeks(±7d) after the operation of argon-helium cryoablation
To evaluate the operational performance of argon-helium cryoablation
questionnaire
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start30 Mar 2023 (estimated)
- Primary completion1 Dec 2024 (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 Lung CancerStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807022
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0202-5
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation
- ClinicalTrials.gov ID
- NCT05807022
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0202-5
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Apr 2023 (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.
The goal clinical trial is to evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation in primary lung cancer and metastatic lung cancer. The main question it aims to answer are:Evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation.
Participants will undergo percutaneous or transbronchial argon-helium cryoablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous or transbronchial argon-helium cryoablation | Experimental | Procedure: Percutaneous or transbronchial argon-helium cryoablation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Primary or metastatic lung cancer with definite pathological diagnosis
- Not suitable for thoracotomy due to serious or serious lung or systemic diseases
- Peripheral lung cancer involves pleura and chest wall, and cannot be completely removed after surgery
- There are indications for surgical resection, but the patient refuses to operate
- Single tumor, maximum diameter ≤ 5cm
Key exclusion criteria (14 listed)
- Serious cardio-cerebral disease or other mental diseases
- Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis
- Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder and multiple pulmonary bullae
- Have a history of immunodeficiency, including HIV test (enzyme-linked immunosorbent assay and Western blotting) positive
- Chemotherapy, radiotherapy, interventional therapy, ablation and surgical treatment within 30 days before surgical treatment
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 |
|---|---|---|
| Percutaneous or transbronchial argon-helium cryoablationThe participants would undergo Percutaneous or transbronchial argon-helium cryoablation. | Procedure or surgery | Percutaneous or transbronchial argon-helium cryoablation |
Primary outcome
Complete response rate and effective rate of target lesions
Time frame: during the operation of argon-helium cryoablation
Enhanced imaging examination (CT, MRI or color Doppler ultrasound)
Complete response rate and effective rate of target lesions
Time frame: 1 week after the operation of argon-helium cryoablation
Enhanced imaging examination (CT, MRI or color Doppler ultrasound)
Complete response rate and effective rate of target lesions
Time frame: 4 weeks(±7d) after the operation of argon-helium cryoablation
Enhanced imaging examination (CT, MRI or color Doppler ultrasound)
4 secondary outcomes
the iceball coverage rate during the procedure
Time frame: during the procedure
Subjects' tolerance of the procedure
Time frame: 1 week after the operation of argon-helium cryoablation
the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score
Time frame: 4 weeks(±7d) after the operation of argon-helium cryoablation
To evaluate the operational performance of argon-helium cryoablation
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous or transbronchial argon-helium cryoablation in people with Lung Cancer, run by China-Japan Friendship Hospital.
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 10 inclusion and 14 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate and effective rate of target lesions (time frame: during the operation of argon-helium cryoablation). The study lists 3 primary outcomes in all. 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 10 Apr 2023.