Interventional Ablation for Early-stage Lung Cancer

NCT07005999 | Active Not Recruiting DMC

• 2 other identifiers: CROC-25-02ES-2025-064-01
• Study Type: observational
• Target: 656
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Lung Cancer (NSCLC); Early Stage Lung Non-Small Cell Carcinoma

Keywords

Intercentional Ablation; Early stage lung cancer; Real-world study

Outcome Measures

Primary Outcomes (1)

• relapse-free survival, RFS

  Time from grouping to relapse or death from any cause or last contact with a surviving patient (whichever occurs first).

  Three years, five years

Secondary Outcomes (5)

• Technical success rate

  Perioperative/Periprocedural

• Pulmonary Function Assessment

  Baseline, 1 month, 3 months, 6 months, 12 months.

• overall survival, OS

  Three years, five years

• local regional resection, LRR

  Within five years

• Security Indicators

  Within six months after surgery

Other Outcomes (2)

• Biological indicators of peripheral blood

  Baseline AND 1 month

• Quality of life score

  Baseline AND 6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with high-risk lung nodules/early stage lung cancer

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Hunan Provincial People's Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Fuda Cancer Hospital, Guangzhou: collaborator
• University of South China Affiliated Nanhua Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Eastern Theater General Hospital,QinHuai District Medical Area: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Emergency General Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The Second Hospital of Anhui Medical University: collaborator
• Huaxi Hospital: collaborator
• Shanghai Chest Hospital: collaborator
• Military 301 Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Disease (Responsible Party)

Guangzhou, Guangdong, 520000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Chengzhi Zhou, Doctor

  Guangzhou Institute of Respiratory Disease (Responsible Party)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 5, 2025
• Study Start: April 12, 2025
• Primary Completion (Estimated): December 21, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

CN (1)