Electromagnetic Navigation Bronchoscopy Guided Ablation Therapy Combined With VATS in the Treatment of Multiple Primary Lung Cancers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Evaluation of ablation efficacy, ORR (objective response rate)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Minutes to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old.
- •The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination.
- •Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is ≤ 3 cm.
- •The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.
Exclusion Criteria
- •The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy.
- •The situation in which the investigators think that the subject is not suitable to participate in this study.
Outcomes
Primary Outcomes
Evaluation of ablation efficacy, ORR (objective response rate)
Time Frame: 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 Outcomes
- 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.)
- 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.)
- Observation of complications of ablation(From date of treatment to the one month after ablation.)
Investigators
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital