NCT05833672

Neoadjuvant Immunotherapy in Locally Advanced Colon Cancers

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: fan li · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Terelizumab	q3w Terelizumab 200mg on day 1 of each cycle
DRUG	CapeOx	Oxaliplatin(130mg/m2) on day 1 of each cycle and Capecitabine:Dose of 1000mg/m2,14days

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-04-27
• Last updated: 2023-04-27

Locations

1 site across 1 country: China