Neoadjuvant CAPOX Plus Ivonescimab Versus CAPOX for Locally Advanced Colon Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT06790212
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    20mg/kg Q3W，D1
  • Oxaliplatin — DRUG
    Oxaliplatin，130mg/m2，D1，Q3W；
  • Capecitabine — DRUG
    Capecitabine，1000mg/m2，po，BID，D1-D14，Q3W

Study Details

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.

Key Dates

Start date
Apr 28, 2025
Status verified
Mar 2025
Primary completion
Aug 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant AK112 combined with chemotherapy
    Three cycles of neoadjuvant treatment with CAPOX plus Ivonescimab, followed by radical surgery 4 to 5 weeks after the last oxaliplatin dose.
  • Active Comparator: Neoadjuvant chemotherapy
    Three cycles of neoadjuvant CAPOX treatment, followed by radical surgery 4 to 5 weeks after the last dose of oxaliplatin.

Primary Outcome Measure

MPR rate [ Time Frame: though 12 weeks neoadjuvant treatment，after surgery completed ]

Central Contacts

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