Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC

Lung cancer is one of the most common malignant tumors worldwide and the mortality ranks first in the world. In recent years, with the development of targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. However, the inoperable advanced tumor remains the main reason for the poor prognosis of lung cancer. Thus, we aim to carry out this single-arm, prospective study to evaluate the safety and feasibility of surgery after conversion therapy for locally advanced and advanced non-small cell lung cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Cancer; Locally Advanced Cancer; Pulmonary Neoplasm
• Intervention / Treatment: Procedure: Surgery

Detailed Description

Previous studies have shown that selective surgery after conversion therapy is feasible and safe in locally advanced or stage IV patients, and indicates potential benefits for these patients. However, surgery after conversion therapy is difficult and has high risk of postoperative complications which requires strict operation indications and patient screening. At present, there are only relevant retrospective studies and no prospective evidence. Therefore, our team plans to carry out this single-arm prospective clinical trial to evaluate the safety and feasibility of surgery in patients with locally advanced and advanced non-small cell lung cancer after conversion therapy, so as to lay the foundation for further research and clinical application.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 021
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent;
• More than 18 years old with no limit of sex;
• Pathologically confirmed stage T4N0-3 or T1-3N2-3 NSCLC with residual tumor after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) evaluated operable for radical resection; pathologically confirmed stage IVA NSCLC evaluated operable after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.);
• ASA score: I-III;
• Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

Exclusion Criteria:

• Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation;
• Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
• Unable to receive radical resection;
• Need of palliative or emergency operation due to lung abscess or hemoptysis;
• Having received neoadjuvant chemoradiotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery after conversion therapy; Participants with locally advanced or advanced NSCLC who received first-line treatment have been evaluated as resectable after multidisciplinary discussion involving the department of thoracic surgery, respiratory medicine, radiology and oncology.	Procedure: Surgery; Participants having been evaluated as operable after receiving first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) will receive surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative morbidity	rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula	postoperative in-hospital stay up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lymph nodes counts	overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station	At operation day
R0 rate	R0 resection rate	postoperative in-hospital stay up to 30 days
operation time	duration of operation	At operation day
blood loss	blood loss in the operation	At operation day
operative complications	rate of adverse events happened in the operation	At operation day
postoperative hospital stay	length of postoperative hospitalization	postoperative in-hospital stay up to 30 days
30-day mortality	30-day mortality after surgery	postoperative in-hospital stay up to 30 days
1-year overall survival (OS)	OS at 1 year after surgery	1 year after surgery
3-year overall survival (OS)	OS at 3 year after surgery	3 year after surgery
1-year disease-free survival (DFS)	DFS at 1 year after surgery	1 year after surgery
3-year disease-free survival (DFS)	DFS at 3 years after surgery	3 year after surgery

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: He-Cheng Li, doctor, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Estimated): June 5, 2024
• Study Completion (Estimated): June 5, 2026

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer; Conversion Therapy; Locally Advanced and Advanced NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RTS-013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No