Lung CancerNCT06453889
Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
A study testing Multimode thermal therapy in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Multimode thermal therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2024to 5 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer);
- The ECOG PS score is 0-2;
- Expected survival ≥6 months;
- Negative driver gene mutation: driver genes were defined as EGFR, ALK, ROS1, RET;
- Agree to undergo multimode thermal therapy as initial treatment after being assessed unsuitable for surgery or refusing surgery, and sign informed consent.
Who cannot join
- Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
- Patients whose chest CT indicated that the lung lesions could not be reached through the chest wall through multimode thermal therapy;
- Severe liver and kidney function and coagulation function abnormalities, platelet count <70×109/L;
- Poor control of malignant pleural effusion;
- Patients who have received other anti-tumor drugs or have used immune checkpoint inhibitors in the past 6 months;
- The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
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- Those who have undergone surgical operations or had allogeneic organ transplants within 1 month;
- Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
- Pregnant and lactating women;
- Long-term use of steroid;
- Other circumstances considered inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, +86-021-22200000 ext. 1511, jysun1976@163.com
About this study
The purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy.
Read the detailed description
This is a single-center, single-arm, exploratory study, and is expected to enroll a total of 10 patients. The enrolled patients were stage IA lung cancer patients with lung lesions found on chest CT, pathologically diagnosed as non-small cell lung cancer, negative for driver gene mutations, and who were considered high-risk or refused surgery by multidisciplinary evaluation. Follow-ups are performed after the multimode thermal therapy. The primary endpoint is complete ablation rate at 6 months after multimode thermal therapy. The secondary endpoints are complete ablation rate at 12 months after multimode thermal therapy, local control rate at 1, 2, 3 years post-procedure, progression-free survival and mmune effects after multimodal thermal therapy.
- Conditions
- Lung Cancer
- Being tested
- Multimode thermal therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimode thermal therapyDevice
The multimode thermal therapy procedure consists of a sequential rapid freezing, natural thawing, and radio-frequency (RF) heating of the target tumor tissue.
| Study group | Role | What they receive |
|---|---|---|
| Multimode thermal therapy | Experimental | Percutaneous multimode thermal therapy Receives: Device: Multimode thermal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ablation rate at 6 months post-procedure
This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months after multimode thermal therapy.
Measured: 6 months
Secondary outcomes (5)
Complete ablation rate at 12 months post-procedure
This refers to the proportion of completely ablated lesions in the total ablated lesions at 12 months after multimode thermal therapy.
Measured: 12 months
Local control rate at 1, 2, 3 years post-procedure
This refers to the proportion of completely and incompletely ablated lesions in the total ablated lesions at 1 year, 2 years and 3 years after multimode thermal therapy.
Measured: 3 years
Progression-free survival
This refers to the length of time between the participant's first onset of disease progression or death from any cause after multimode thermal therapy.
Measured: 3 years
Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines)
This refers to the changes from baseline in the immunological responses following the multimode thermal therapy, including the percentage and function of lymphocyte phenotypes, the expression of PD-L1, the concentration of IL-6/IL-17A levels, etc.
Measured: 3 months
Number of participants with adverse events
This refers to all treatment-related adverse events (grade 1- 5) occurring during the trial and follow-up period as assessed by CTCAE v5.0.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start5 Jun 2024 (estimated)
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2027 (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 Shanghai Chest 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
- Model description
- multimode thermal therapy
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453889
- Sponsor's protocol ID
- KS24015
- Status last verified
- Jun 2024
- First submitted
- 25 May 2024
- Last updated
- 12 Jun 2024
- 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
- ClinicalTrials.gov ID
- NCT06453889
- Acronym / sponsor ID
- KS24015
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 5 Jun 2024 (estimated)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2027 (estimated)
- First posted
- 12 Jun 2024 (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 purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy.
Detailed description
This is a single-center, single-arm, exploratory study, and is expected to enroll a total of 10 patients. The enrolled patients were stage IA lung cancer patients with lung lesions found on chest CT, pathologically diagnosed as non-small cell lung cancer, negative for driver gene mutations, and who were considered high-risk or refused surgery by multidisciplinary evaluation. Follow-ups are performed after the multimode thermal therapy. The primary endpoint is complete ablation rate at 6 months after multimode thermal therapy. The secondary endpoints are complete ablation rate at 12 months after multimode thermal therapy, local control rate at 1, 2, 3 years post-procedure, progression-free survival and mmune effects after multimodal thermal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multimode thermal therapy
| Arm | Type | Receives |
|---|---|---|
| Multimode thermal therapy | Experimental | Device: Multimode thermal therapyPercutaneous multimode thermal therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old;
- Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer);
- The ECOG PS score is 0-2;
- Expected survival ≥6 months;
- Negative driver gene mutation: driver genes were defined as EGFR, ALK, ROS1, RET;
Key exclusion criteria (11 listed)
- Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
- Patients whose chest CT indicated that the lung lesions could not be reached through the chest wall through multimode thermal therapy;
- Severe liver and kidney function and coagulation function abnormalities, platelet count <70×109/L;
- Poor control of malignant pleural effusion;
- Patients who have received other anti-tumor drugs or have used immune checkpoint inhibitors in the past 6 months;
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 |
|---|---|---|
| Multimode thermal therapyThe multimode thermal therapy procedure consists of a sequential rapid freezing, natural thawing, and radio-frequency (RF) heating of the target tumor tissue. | Device | Multimode thermal therapy |
Primary outcome
Complete ablation rate at 6 months post-procedure
Time frame: 6 months
This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months after multimode thermal therapy.
5 secondary outcomes
Complete ablation rate at 12 months post-procedure
Time frame: 12 months
Local control rate at 1, 2, 3 years post-procedure
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines)
Time frame: 3 months
Number of participants with adverse events
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- 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.
Jiayuan Sun study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimode thermal therapy in people with Lung Cancer, run by Shanghai Chest 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 11 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: opening soon, as of the sponsor's last update on 12 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun (+86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate at 6 months post-procedure (time frame: 6 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 12 Jun 2024.