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Local Therapy for Oligometastatic Esophageal Squamous Cell Cancer Patients Treated With PD-1 Inhibitor: a Prospective, Randomized, Phase III Clinical Trial.

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma

Clinical Trial Summary

Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone. The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

Clinical Trial Description

Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radiofrequency/microwave ablation, etc.) or PD-1 inhibitor +/- chemotherapy alone. Different local therapy techniques are allowed to be used on different lesions in the same patient.All suspected malignant lesion should be included in local treatment planning in principle. The primary end point was progression-free survival (PFS). The second end points included overall survival, side effects and local control. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06190782
Study type Interventional
Source Fudan University
Contact Qi Liu, MD
Phone 86-18017317882
Email 18017317882@163.com
Status Recruiting
Phase Phase 3
Start date September 27, 2022
Completion date September 27, 2027
View Details
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