Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis

Status Recruiting

Clinical Trial Summary

This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.

Clinical Trial Description

This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (gemcitabine and nab-paclitaxel) in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion and liver metastases will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06405685
Study type	Interventional
Source	Tianjin Medical University Cancer Institute and Hospital
Contact	Huikai Li, Dr
Phone	186 2222 8639
Email	tjchlhk@126.com
Status	Recruiting
Phase	Phase 2
Start date	April 27, 2023
Completion date	October 30, 2025

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