NCT05951127

Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC

Additional Local Consolidative Esophagectomy to Traditional Systemic Therapy for Patients With Oligometastatic Resectable ESCC: A Multi-center, Open-label, Randomized Controlled Tial (LEO)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

At present, there are relatively clear treatment guidelines for colorectal cancer with oligometastases, while the treatment mode for resectable esophageal cancer with oligometastases is not clear and there is a lack of research results in this field. The aim of this study is to provide evidence of the optimal therapy model for the local resectable esophageal cancer with oligometastases ESCC patients, by investigating whether 2-year OS of the patients could benefit from additional local consolidative esophagectomy.

Detailed description

This study was designed as a multicenter, open-label, randomized controlled prospective clinical study. The experimental group (group A) received additional esophagectomy after 3-month systemic treatment, and the control group (group B) received only systemic treatment. 2-year OS, 3-year PFS and OS were observed in the two groups.

Conditions

• Esophageal Squamous Cell Carcinoma
• Oligometastatic Disease

Interventions

Type	Name	Description
PROCEDURE	Esophagectomy	Esophagectomy for esophageal cancer and regional lymph nodes dissection.

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

2 sites across 1 country: China