NCT06790212

Neoadjuvant CAPOX Plus Ivonescimab Versus CAPOX for Locally Advanced Colon Cancer

A Prospective, Randomized Phase II Study Evaluating CAPOX Combined with Ivonescimab (a PD-1/VEGF-A Bispecific Antibody) Versus CAPOX Alone As Neoadjuvant Therapy in Patients with Locally Advanced Colon Cancer.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant chemotherapy has been validated by several clinical studies to achieve preoperative downstaging and improve survival outcomes in patients with locally advanced colon cancer . Enhancing the efficacy of neoadjuvant treatment further represents a crucial direction for future research. Recognizing the potential of synergistic effects between immunotherapy and anti-angiogenic therapy, the investigators conducted the present randomized study to explore whether Ivonescimab （a PD-1/VEGF bispecific-antibody）combined with neoadjuvant chemotherapy in locally advanced colon cancer could potentially further improve treatment outcomes.

Detailed description

This phase II, prospective, randomized controlled trial aims to evaluate the efficacy and safety of combining CAPOX chemotherapy with Ivonescimab, a PD-1/VEGF-A bispecific antibody, compared to neoadjuvant CAPOX therapy alone in patients with high-risk recurrent MSS/pMMR-type colon cancer.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Ivonescimab	20mg/kg Q3W，D1
DRUG	Oxaliplatin	Oxaliplatin，130mg/m2，D1，Q3W；
DRUG	Capecitabine	Capecitabine，1000mg/m2，po，BID，D1-D14，Q3W

Timeline

• Start date: 2025-04-28
• Primary completion: 2027-08-30
• Completion: 2028-06-30
• First posted: 2025-01-23
• Last updated: 2025-03-17