Neoadjuvant Immunotherapy in Locally Advanced Colon Cancers

Status Not yet recruiting

Clinical Trial Summary

The aim of this study is to evaluate the safety and efficacy of neoadjuvant immunotherapy combined with chemotherapy before colonic resection in patients with locally advanced colon cancers

Clinical Trial Description

The trial is designed as an investigator-initiated, single center, prospective, single arm phase II study in patients with locally advanced colon cancers scheduled for intended curative surgery to determine the efficacy of immunotherapy using tislelizumab in the neoadjuvant setting. Patients will receive CapeOX + Terelizumab therapy(Day 1 through Day 21) following diagnosis. After 3 weeks a re-evaluation (to assess tumor response) will be performed, followed by standard surgery for resection of the tumor. Surgery will therefore be performed within 3 to 5 weeks after 2 cycle of neoadjuvant combined immunotherapy.. The patients will be followed as per the standard Danish guidelines with CT scans at 1 and 3 years after surgery. The specimen collected by surgery and clinical data will be collected . We use Integrative omics analysis to establish a clinical efficacy prediction model by means of bioinformatics to prospectively judge the efficacy and guide the follow-up individualized and accurate treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05833672
Study type	Interventional
Source	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact	fan L [fli]
Phone	86 023 68757958
Email	levinecq@163.com
Status	Not yet recruiting
Phase	Phase 2
Start date	May 1, 2023
Completion date	December 31, 2025

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