Lung Cancer (NSCLC)NCT07005999
Interventional Ablation for Early-stage Lung Cancer
An observational study of Lung Cancer (NSCLC) and Early Stage Lung Non-Small Cell Carcinoma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Lung Cancer (NSCLC), Early Stage Lung Non-Small Cell Carcinoma
- How many people
- 656 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2025to 31 Dec 2028
- Phase
- Observational
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high-risk lung nodules/early stage lung cancer
Who may be able to join
- Age of 20-79 years;
- Eastern Cooperative Oncology Group Physical Status (ECOG PS) score of 0-2;
- Enhanced CT of the chest: suspicious malignant signs of lung nodules, such as lobar sign, burr sign, pleural depression sign, bronchial insufflation sign, vacuolar sign, vascular cluster sign, or signs of twisted dilatation of blood vessels within the nodule and cystic cavity type, with no more than 3 lesions bilaterally or unilaterally, and no lymph node metastasis;
- Thin-section CT of the chest: maximum diameter of the lesion > 5mm ≤ 2cm, solid/tumour ratio CTR ≤ 0.25;
- Adequate haematological, renal and hepatic functions:
- Haematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, haemoglobin (HGB) ≥9 g/dL;
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- Liver function: serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 times the ULN, serum albumin (ALB) ≥2.8 g/dL;
- Renal function: serum creatinine (Cr) ≤ 1.5 x ULN, or creatinine clearance ≥ 40 mL/min;
- Subjects and subject sexual partners are required to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms, etc.) during the study treatment period and for 6 months after the end of the study treatment period; (7) Subjects must sign a written informed consent form approved by the IRB/IEC in accordance with competent authorities and study site guidelines, and be able to comply with protocol-specified visits, treatment regimens, laboratory investigations, and related procedures.
- Haematology Neutrophils (ANC) ≥1.5 x 109/L Platelets (PLT) ≥100×109/L Haemoglobin (Hb) ≥90g/L Liver Function Total bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN) Glutamate aminotransferase (ALT) ≤2.5 × ULN; for patients with liver metastases ≤5 × ULN; Aspartate aminotransferase (AST) ≤2.5 x ULN; for patients with liver metastases ≤5 x ULN; Renal function Creatinine (Cr) ≤1.5×ULN; if >1.5×ULN, creatinine clearance ≥50 mL/min (calculated according to the Cockcroft-Gault formula) Coagulation Activated partial thromboplastin time (APTT) ≤1.5×ULN Prothrombin time (PT) or International Normalised Ratio (INR) ≤1.5 x ULN
Who cannot join
- Nodule adjacent to or encircling a large mediastinal vessel (e.g., aorta, superior vena cava, main pulmonary artery, main pulmonary vein, etc.), with a distance from the vessel <5 mm;
- Subpleural nodules (<5 mm from the pleura);
- patients with regional lymph node metastasis or distant metastasis confirmed by chest enhanced CT/HRCT;
- patients with severe bleeding tendency, coagulation dysfunction that cannot be corrected within a short period of time (prothrombin time >18 s, prothrombin activity <40%) and/or platelet count <50 × 109/L;
- severe interstitial pneumonia, severe pulmonary fibrosis or severe emphysema;
- malignant pleural effusion;
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- treatment for the following:
- received systemic anti-tumour therapy such as chemotherapy, targeted therapy, immunotherapy, etc;
- Received any investigational drug therapy;
- High dose immunosuppressive drugs (systemic glucocorticoids greater than 10mg/day prednisone or its equivalent) within 4 weeks prior to the entry assessment;
- Received a live attenuated vaccine within 4 weeks prior to the entry assessment (or plan to receive a live attenuated vaccine during the study period);
- Major surgery (e.g., open heart, open chest, or open abdomen) or unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to the enrolment assessment;
- Have another uncontrolled serious medical condition, including but not limited to:
- Serious infections that are active or not well controlled clinically;
- HIV infected (HIV antibody positive);
- Acute or chronic active hepatitis B (HBV DNA positive) or acute or chronic active hepatitis C (HCV antibody positive);
- Active tuberculosis, etc;
- Class III-IV congestive heart failure (New York Heart Association classification) with poorly controlled and clinically significant arrhythmias;
- Uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Any arterial thrombosis, embolism or ischaemia such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischaemic attack within 6 months prior to enrolment for treatment;
- Diseases requiring anticoagulant therapy with Favalin (Coumadin);
- Uncontrolled hypercalcaemia (greater than 1.5 mmol/L Ca2+ or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN) or symptomatic hypercalcaemia requiring continued bisphosphonate therapy;
- concomitant other malignancies (except those that have been eradicated, e.g., carcinoma in situ of the uterine cervix, non-melanoma skin cancer, etc.); and
- Other acute or chronic medical conditions, psychiatric disorders, or abnormal laboratory test values that may result in: increased risk associated with study participation or administration of study medication, or interference with the interpretation of study results, and that, in the investigator's judgement, classifies the patient as ineligible for participation in this study;
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Disease (Responsible Party)
Guangzhou, Guangdong, 520000
About this study
Official title: The Safety and Efficacy of Interventional Ablation for High-risk Pulmonary Nodules or Early-stage Lung Cancer: A Multicenter, Prospective, Real-World Study
What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function.
Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function.
Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease.
Read the detailed description
What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function.
Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function.
Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease.
Who can participate? Adults aged 20-79 with high-risk lung nodules or early lung cancer.
Eligibility criteria:
Nodules ≤2 cm on CT scan, no lymph node/distant spread. Good overall health (e.g., normal blood/organ function, no severe heart/lung disease).
No recent cancer treatments (e.g., chemotherapy, radiation). Exclusions: Nodules near major blood vessels/chest wall, pregnancy, or uncontrolled medical conditions.
What does the study involve?
Two treatment groups:
Ablation group: Destroy tumors using heat (microwave) or cold (cryoablation). Surgery group: Remove tumors via standard surgery. Follow-up: Regular check-ups for 5 years, including CT scans, lung function tests, and blood work.
What are the potential risks? Ablation risks: Pain, bleeding, infection, pneumothorax (collapsed lung), or damage to nearby organs.
Surgery risks: Infection, prolonged pain, lung complications (e.g., reduced function), or longer recovery.
Both groups may experience recurrence or side effects like fatigue. What are the benefits? Direct benefits: Access to advanced treatments, close monitoring, and potential lung function preservation with ablation.
Long-term impact: Help future patients by improving treatment options for early lung cancer.
Study Timeline and Locations Duration: 2024-2028 (participants followed for up to 5 years). Locations: 18+ major hospitals across China, including Guangzhou Medical University Affiliated Hospital (lead center), West China Hospital, and Shanghai Chest Hospital.
Key Outcomes Measured Relapse-free survival: Time without cancer returning. Safety: Rates of complications (e.g., bleeding, infection). Lung function: Preserved breathing capacity after treatment. Quality of life: Physical and emotional well-being post-treatment. How will results be used? Findings will guide doctors in choosing the best treatment for early lung cancer, balancing effectiveness with quality of life. Results will be published in medical journals and shared at conferences.
Contact Information
For questions or enrollment:
Lead Researcher: Dr. Zhou Chengzhi, Respiratory Medicine, Guangzhou Medical University Affiliated Hospital.
Local Sites: Contact participating hospitals listed in the study document. Ethical Approval: This study follows strict ethical guidelines to protect participants. All treatments are voluntary, and participants may withdraw at any time.
- Keywords
- Intercentional Ablation, Early stage lung cancer, Real-world study
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposure Group(A) | Subjects were entered into the exposure group because they chose interventional ablation therapy and agreed to be enrolled in this real-world study. | |
| Control Group(B) | Subjects were entered into the control group because they chose surgical resection treatment and agreed to be enrolled in this real-world study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse-free survival, RFS
Time from grouping to relapse or death from any cause or last contact with a surviving patient (whichever occurs first).
Measured: Three years, five years
Secondary outcomes (5)
Technical success rate
- When the tumour is treated according to a predetermined protocol with complete overlap of the ablation area (ablation border > tumour border by at least 5 mm), the operation is defined as a technical success when imaging follow-up demonstrates complete macroscopic ablation of the tumour, and technical success is defined as the percentage of the calculation of technical success.
Measured: Perioperative/Periprocedural
Pulmonary Function Assessment
The process of quantitatively analysing and comprehensively evaluating the functional status of the patient's lungs, such as ventilation and gas exchange, by measuring the patient's first-second force expiratory volume (FEV1) and forceful lung capacity (FVC).
Measured: Baseline, 1 month, 3 months, 6 months, 12 months.
overall survival, OS
Time from grouping to death from any cause or last contact with surviving patient (whichever occurs first).
Measured: Three years, five years
local regional resection, LRR
Proportion of tumours with cancer metastases reappearing at the primary site or elsewhere within the same lobe of the lung or in the lung or draining hilar lymph nodes after receiving treatment.
Measured: Within five years
Security Indicators
Adverse event rates, and operation-related adverse event rates throughout the study: adverse events occurring within 30 days of ablation treatment and operation-related adverse events of surgical treatment (AE\&SAE), evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Measured: Within six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start12 Apr 2025
- Primary completion21 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Provincial People's Hospital, Beijing Chao Yang Hospital, Fuda Cancer Hospital, Guangzhou, University of South China Affiliated Nanhua Hospital, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Guangzhou Medical University, Sir Run Run Shaw Hospital, Eastern Theater General Hospital,QinHuai District Medical Area, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Emergency General Hospital, The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University, Huaxi Hospital, Shanghai Chest Hospital, Chinese PLA General Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Chengzhi Zhou, Doctor, Study director, Guangzhou Institute of Respiratory Disease (Responsible Party)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005999
- Sponsor's protocol ID
- CROC-25-02
- Other IDs
- ES-2025-064-01
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Interventional Ablation for High-risk Pulmonary Nodules or Early-stage Lung Cancer: A Multicenter, Prospective, Real-World Study
- ClinicalTrials.gov ID
- NCT07005999
- Acronym / sponsor ID
- CROC-25-02
- Keywords
- Intercentional Ablation, Early stage lung cancer, Real-world study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Hunan Provincial People's Hospital, Beijing Chao Yang Hospital, Fuda Cancer Hospital, Guangzhou, University of South China Affiliated Nanhua Hospital, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Guangzhou Medical University, Sir Run Run Shaw Hospital, Eastern Theater General Hospital,QinHuai District Medical Area, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Emergency General Hospital, The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University, Huaxi Hospital, Shanghai Chest Hospital, Chinese PLA General Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- 21 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jun 2025 (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.
What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function.
Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function.
Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease.
Detailed description
What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function.
Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function.
Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease.
Who can participate? Adults aged 20-79 with high-risk lung nodules or early lung cancer.
Eligibility criteria:
Nodules ≤2 cm on CT scan, no lymph node/distant spread. Good overall health (e.g., normal blood/organ function, no severe heart/lung disease).
No recent cancer treatments (e.g., chemotherapy, radiation). Exclusions: Nodules near major blood vessels/chest wall, pregnancy, or uncontrolled medical conditions.
What does the study involve?
Two treatment groups:
Ablation group: Destroy tumors using heat (microwave) or cold (cryoablation). Surgery group: Remove tumors via standard surgery. Follow-up: Regular check-ups for 5 years, including CT scans, lung function tests, and blood work.
What are the potential risks? Ablation risks: Pain, bleeding, infection, pneumothorax (collapsed lung), or damage to nearby organs.
Surgery risks: Infection, prolonged pain, lung complications (e.g., reduced function), or longer recovery.
Both groups may experience recurrence or side effects like fatigue. What are the benefits? Direct benefits: Access to advanced treatments, close monitoring, and potential lung function preservation with ablation.
Long-term impact: Help future patients by improving treatment options for early lung cancer.
Study Timeline and Locations Duration: 2024-2028 (participants followed for up to 5 years). Locations: 18+ major hospitals across China, including Guangzhou Medical University Affiliated Hospital (lead center), West China Hospital, and Shanghai Chest Hospital.
Key Outcomes Measured Relapse-free survival: Time without cancer returning. Safety: Rates of complications (e.g., bleeding, infection). Lung function: Preserved breathing capacity after treatment. Quality of life: Physical and emotional well-being post-treatment. How will results be used? Findings will guide doctors in choosing the best treatment for early lung cancer, balancing effectiveness with quality of life. Results will be published in medical journals and shared at conferences.
Contact Information
For questions or enrollment:
Lead Researcher: Dr. Zhou Chengzhi, Respiratory Medicine, Guangzhou Medical University Affiliated Hospital.
Local Sites: Contact participating hospitals listed in the study document. Ethical Approval: This study follows strict ethical guidelines to protect participants. All treatments are voluntary, and participants may withdraw at any time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Group(A) | – | –Subjects were entered into the exposure group because they chose interventional ablation therapy and agreed to be enrolled in this real-world study. |
| Control Group(B) | – | –Subjects were entered into the control group because they chose surgical resection treatment and agreed to be enrolled in this real-world study. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high-risk lung nodules/early stage lung cancer
Key inclusion criteria (10 listed)
- Age of 20-79 years;
- Eastern Cooperative Oncology Group Physical Status (ECOG PS) score of 0-2;
- Enhanced CT of the chest: suspicious malignant signs of lung nodules, such as lobar sign, burr sign, pleural depression sign, bronchial insufflation sign, vacuolar sign, vascular cluster sign, or signs of twisted dilatation of blood vessels within the nodule and cystic cavity type, with no more than 3 lesions bilaterally or unilaterally, and no lymph node metastasis;
- Thin-section CT of the chest: maximum diameter of the lesion > 5mm ≤ 2cm, solid/tumour ratio CTR ≤ 0.25;
- Adequate haematological, renal and hepatic functions:
Key exclusion criteria (25 listed)
- Nodule adjacent to or encircling a large mediastinal vessel (e.g., aorta, superior vena cava, main pulmonary artery, main pulmonary vein, etc.), with a distance from the vessel <5 mm;
- Subpleural nodules (<5 mm from the pleura);
- patients with regional lymph node metastasis or distant metastasis confirmed by chest enhanced CT/HRCT;
- patients with severe bleeding tendency, coagulation dysfunction that cannot be corrected within a short period of time (prothrombin time >18 s, prothrombin activity <40%) and/or platelet count <50 × 109/L;
- severe interstitial pneumonia, severe pulmonary fibrosis or severe emphysema;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relapse-free survival, RFS
Time frame: Three years, five years
Time from grouping to relapse or death from any cause or last contact with a surviving patient (whichever occurs first).
5 secondary outcomes
Technical success rate
Time frame: Perioperative/Periprocedural
Pulmonary Function Assessment
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months.
overall survival, OS
Time frame: Three years, five years
local regional resection, LRR
Time frame: Within five years
Security Indicators
Time frame: Within six months after surgery
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 5 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Chengzhi Zhou, Doctor study director
Guangzhou Institute of Respiratory Disease (Responsible Party)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC) and Early Stage Lung Non-Small Cell Carcinoma, run by Guangzhou Institute of Respiratory Disease 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 10 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse-free survival, RFS (time frame: Three years, five years). 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 5 Jun 2025.