ENB-guided Ablation Therapy Combined With VATS in the Treatment of MPLC

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT04730453
• Lead Sponsor: Shanghai Chest Hospital

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 Timeline

• Study Start: 2020-07-24
• Status Verified: 2021-01
• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-01-29
• Last Update Posted: 2021-01-29
• Primary Completion: 2025-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China