Lung Cancer
Conditions
Keywords
Cryoablation, Lung cancer, Transbronchial ablation, Transthoracic ablation
Brief summary
The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.
Detailed description
Ablation therapy has been widely used in the treatment of peripheral lung cancer. Among various ablation techniques, cryoablation has been demonstrated to be therapeutic efficacy with several advantages, including high safety, clear ablation borders, and minimal local pain. With the development of navigational bronchoscopy, pilot study on transbronchial cryoablation for peripheral lung cancer has proved its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term as well as long-term efficacy and safety. This study was designed as a prospective, randomized controlled, multicenter clinical trial. A total of 110 participants will be randomly assigned to either the transbronchial group or the transthoracic group in a 1:1 ratio. The primary endpoint is the complete ablation rate at 12 months post-ablation. Secondary endpoints include technical success rate, complete ablation rate at 6 months post-ablation, local control rate at 1, 2 and 3 years post-ablation, progression-free survival, overall survival, and safety.
Interventions
DEVICETransthoracic cryoablation
Transthoracic cryoablation will be performed under the guidance of CT.
DEVICETransbronchial cryoablation
Transbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.
Sponsors
Jiayuan Sun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age older than 18 years. 2. Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary). 3. The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation. 4. Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form.
Exclusion criteria
1. Patients with platelets \<70×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short term. 2. Patients with severe pulmonary fibrosis and pulmonary arterial hypertension. 3. Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever \>38.5°C. 4. Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in a short term. 5. Those with poorly controlled malignant pleural effusions. 6. Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5\ 7d before ablation. 7. Eastern Cooperative Oncology Group (ECOG) score \>2. 8. Combination with other tumors with extensive metastases and an expected survival of \<6 months. 9. Patients with episodic psychosis. 10. Pregnant women, or patients with pregnancy plan during the study period. 11. Have participated or are participating in other clinical studies within 30 days. 12. Any other condition that the investigator considers inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete ablation rate at 12 months | Twelve months post-ablation | Twelve months after the overall ablation procedure, the proportion that subjects whose lesion recevied ablation maintain completely ablated account for all evaluable subjects who receive cryoablation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete ablation rate at 6 months | Six months post-ablation | Six months after the overall ablation procedure, the proportion that subjects whose lesion recevied ablation maintain completely ablated account for all evaluable subjects who receive cryoablation. |
| Local control rates at 1, 2 and 3 years postoperatively | 12, 24, 36 monthspost-ablation | The number of lesions with complete and incomplete ablation at 1, 2, and 3 years after ablation treatment as a proportion of the number of all ablation-treated lesions. |
| Technical success rate | Immediately after Each Operation | It is defined as the number of lesions for which the ablation needle reached the location of the lesion and was successfully ablated as a proportion of the total number of lesions to be ablated, as assessed by immediate post-ablation imaging |
| Overall survival（OS） | From the time of treatment to the time of the patient death, up to 36 months | Overall survival（OS) is evaluated after the treatment of ablation until the patient death. |
| Adverse event | Twelve months psot-ablation | All adverse events will be recorded during operation and during the follow-up, and be evaluated according to the CTCAE v5.0. Related and possible related AEs and SAEs will be determined and evaluated. |
| Progression-free survival (PFS) | From the time of treatment to the time of disease progression or death (determined by the one which occurs first), up to 36 months | PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death. |
Countries
China
Contacts
Primary ContactJiayuan Sun, PhD
Outcome results
None listed