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

Shanghai Chest Hospital30 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lung Cancer

Interventions

ENB-guided ablation therapy combined with VATSPROCEDURE

After receiving multidisciplinary assessments, Lesion A will receive ENB-guided ablation therapy and Lesion B will receive VATS at the same time.

Eligibility

Sex: ALLMin age: 18 Minutes

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Evaluation of ablation efficacy, ORR (objective response rate)

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).

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.

Secondary Outcomes

Evaluation of ablation efficacy, PFS (progression-free survival)

PFS is defined as the time from the start of treatment to the first occurrence of disease progression or death for any cause.

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 3 years.

Evaluation of ablation efficacy, OS (overall survival)

OS is defined as the time from the start of treatment to the death of the patient.

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 5 years.

Observation of complications of ablation

Complications refer to the combination of serious adverse events related to the operation during or after the operation, mainly including pneumothorax and bleeding.

Time frame: From date of treatment to the one month after ablation.

Central Contacts

Jiayuan Sun, MD, PhD

CONTACT

+86-021-22200000 xkyyjysun@163.com

Data from ClinicalTrials.gov

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