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Spots Global Cancer Trial Database for Neoadjuvant Immunotherapy in Locally Advanced Colon Cancers

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Trial Identification

Brief Title: Neoadjuvant Immunotherapy in Locally Advanced Colon Cancers

Official Title: Single Arm Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Locally Advanced Colon Cancers

Study ID: NCT05833672

Interventions

Terelizumab
CapeOx

Study Description

Brief 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

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Daping hospital, Chongqing, , China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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