Lung Cancer
Conditions
Keywords
Electromagnetic Navigation Bronchoscopy (ENB), Video-Assisted Thoracic Surgery (VATS), Multiple Primary Lung Cancers (MPLC), Ablation Therapy
Brief summary
The study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC).
Detailed description
Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive ENB-guided ablation therapy combined with VATS. The primary endpoint is objective response rate (ORR). The secondary endpoints include progression-free survival (PFS), overall survival (OS) and safety.
Interventions
PROCEDUREENB-guided ablation therapy combined with VATS
After receiving multidisciplinary assessments, Lesion A will receive ENB-guided ablation therapy and Lesion B will receive VATS at the same time.
Sponsors
Shanghai Chest Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Minutes to No maximum
Inclusion criteria
1. Age ≥ 18 years old. 2. The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination. 3. Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is ≤ 3 cm. 4. The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.
Exclusion criteria
1. The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy. 2. The situation in which the investigators think that the subject is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of ablation efficacy, ORR (objective response rate) | From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years. | ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) after ablation therapy. Efficacy evaluation is based on Modifield Response Evaluation Criteria in Solid Tumors (mRECIST). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of ablation efficacy, PFS (progression-free survival) | From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years. | PFS is defined as the time from the start of treatment to the first occurrence of disease progression or death for any cause. |
| Evaluation of ablation efficacy, OS (overall survival) | From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years. | OS is defined as the time from the start of treatment to the death of the patient. |
| Observation of complications of ablation | From date of treatment to the one month after ablation. | Complications refer to the combination of serious adverse events related to the operation during or after the operation, mainly including pneumothorax and bleeding. |
Countries
China
Contacts
Primary ContactJiayuan Sun, MD, PhD
Outcome results
None listed