An interventional study of Cryoablation in Lung Cancer, sponsored by Ruijin Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
Lung cancer is the leading cause of cancer-related mortality worldwide, making early diagnosis and intervention critical. With the widespread adoption of low-dose computed tomography (LDCT) screening, the detection rate of pulmonary ground-glass nodules (GGNs) has increased significantly. Although video-assisted thoracoscopic surgery (VATS) remains the standard treatment for early-stage lung cancer, a considerable proportion of patients are ineligible for surgery due to advanced age, impaired cardiopulmonary function, or multiple nodules. Cryoablation, a minimally invasive ablation technique, uses ultra-low temperatures to induce tumor cell death. It offers distinct advantages, including well-defined ablation margins, reduced procedural pain, preservation of adjacent healthy structures, and potential immune activation, providing an important alternative for this patient population. However, the safety and long-term efficacy of cryoablation for GGNs require further high-quality clinical evidence.
This study aims to conduct a prospective, single-center, open-label clinical trial to systematically evaluate the feasibility and outcomes of cryoablation (percutaneous or electromagnetic navigation bronchoscopy [ENB]-guided) for treating pulmonary GGNs. We plan to enroll 90 patients who meet the following criteria: pathologically or multidisciplinary team (MDT)-confirmed malignancy, GGN size ranging from 6-30 mm, solid component ratio \<25%, unsuitability for or refusal of surgery/radiotherapy, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The primary endpoint is the 2-year local recurrence rate after ablation. Secondary endpoints include the 5-year local recurrence rate, 3- and 5-year disease-free survival (DFS) rates, technical success rate (ablation completion), perioperative complications (e.g., pneumothorax, hemorrhage, infection), postoperative pulmonary function, pain scores, length of hospital stay, and treatment-related costs. The results of this study will provide critical clinical evidence to support the use of cryoablation for GGNs, optimize patient selection criteria, and promote the advancement of this minimally invasive technique.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For a solitary GGN: size between 6-30 mm. For multiple GGNs: each measuring 6-30 mm, with no more than 3 nodules deemed to require treatment upon MDT consensus.
Exclusion Criteria:
Procedure: Cryoablation
Following enrollment, patients will undergo comprehensive preoperative evaluations, including thoracic computed tomography (CT), echocardiography, pulmonary function tests, electrocardiography, and laboratory blood tests, to confirm eligibility and exclude any contraindications. Eligible patients will be admitted for cryoablation, performed either percutaneously or under electromagnetic navigation bronchoscopy (ENB) guidance, followed by a structured postoperative follow-up regimen.
2-Year Local Recurrence Rate
Time frame: At 2 Years Post-Treatment
Technical Success Rate
Time frame: Perioperative
Plan to share: Yes — Deidentified participant data
Supporting information: Study protocol, Sap, Icf, Csr
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