Doctors test freezing technique to zap lung cancer without surgery
NCT ID NCT07301411
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new way to treat small lung tumors by freezing them. Doctors use a special scope to guide a freezing probe directly to the tumor. The trial includes 40 adults with early-stage or limited metastatic lung cancer. The goal is to see if the procedure is safe and can completely destroy the tumor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cryoablation therapy device
- What this could lead to
- If successful, this could offer a less invasive treatment option for small lung tumors, potentially reducing the need for surgery.
- What could go wrong
- This is an early exploratory trial with only 40 participants, so results may not apply to everyone. The procedure carries risks like bleeding or incomplete tumor destruction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 to 80 years old (inclusive), male or female; 2. Primary peripheral lung cancer, with pre-treatment staging examination indicating clinical stage T1N0M0, IA (including new onset and multiple primary lesions after treatment); or metastatic lung tumor, with the primary lesion completely removed or well controlled; 3. The maximum diameter of the tumor is ≤3 cm; 4. The number of tumors is ≤3 (no limit for multiple primary lung cancer subjects); 5. Subjects who decline or are deemed unsuitable for surgery per multidisciplinary team's discretion; 6. Subjects who decline or are deemed unsuitable for radiotherapy per investigator's discretion; 7. Subjects whose lesions to be ablated are assessed to be feasible for bronchoscopy-guided cryoablation per investigator's discretion; 8. Subjects who are willing to participate in the study and sign the written informed consent. Exclusion Criteria: 1. Subjects with diffuse lesions in both lungs whose condition cannot be improved by ablation treatment; 2. Subjects whose examination within 1 month prior to treatment suggests intrathoracic lymph node metastasis or extrapulmonary metastasis (except for those whose extrapulmonary metastasis is controlled by local treatment); 3. With reference to the Guidelines for the Application of Diagnostic Flexible Bronchoscopy for Adults (2019 Edition) \[1\], subjects with contraindications for bronchoscopy, such as acute myocardial infarction (within 4 weeks), active massive hemoptysis, platelet count \< 60×109/L, malignant arrhythmia, unstable angina, severe cardiopulmonary insufficiency, hypertensive crisis, severe pulmonary hypertension, intracranial hypertension, acute cerebrovascular events (i.e. cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, intracranial venous thrombosis, etc.), aortic dissection, aortic aneurysm, and systemic extreme failure; 4. Subjects who are using antiplatelet or anticoagulant drugs and cannot be properly managed before treatment (properly managed including clopidogrel terminated 7 days before treatment, ticagrelor terminated 5 days before treatment, warfarin terminated 5 days before treatment, low molecular weight heparin terminated 24 hours before treatment, etc.); 5. Subjects with severe bleeding tendency, uncorrectable coagulation dysfunction; 6. Subjects with electrically or magnetically activated devices implanted or metallic implants (non-titanium); 7. Subjects with other tumors and extensive metastasis, with an expected survival of less than 12 months; 8. Poor general condition (e.g. systemic multiple metastases, severe infection, high fever), infectious and radioactive inflammation around the focus, obvious cachexia, serious dysfunction of important organs, severe anemia and nutritional metabolism disorder that cannot be improved in a short time; 9. The subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of \>2 (See Appendix 1 for details of ECOG scoring criteria); 10. Subjects having received radiotherapy within the past 6 months for the lesion to be ablated; 11. Subjects expected to participate in any other experimental or invasive clinical study within 12 months of the ablation procedure; 12. Subjects with a history of active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive) or, in the investigator's judgment, conditions that may affect the subject's treatment; 13. Those with epilepsy, psychiatric history or cognitive impairment; 14. Pregnant, lactating women, and subjects who are unwilling to use reasonable contraception during the clinical trial; 15. Subjects who had participated or are participating in a drug clinical trial within 3 months (participants in non-interventional trials can be included), or who had participated or are participating in another medical device clinical trial within 1 month (participants in non-interventional trials can be included); 16. Other circumstances which are considered by the investigator not suitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese University of Hong Kong, Prince of Wales Hospital
NOT_YET_RECRUITINGShatin, Hong Kong
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Shanghai Chest Hospital
RECRUITINGShanghai, Shanghai Municipality, 200030, China
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