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.
Sponsor: Sun Yat-sen University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
MPR rate
Time frame: though 12 weeks neoadjuvant treatment,after surgery completed
Secondary Endpoints
Pathologic complete response,pCR
R0 resection rate
Disease free survival
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed locally advanced resectable colon adenocarcinoma (colon cancer located more than 12 cm from the anal verge); 2. Imaging staging is T4, or T3 (with invasion of the muscularis propria ≥5 mm) combined with at least one of the following risk factors: number of metastatic lymph nodes ≥1, extramural vascular invasion (EMVI+), involvement of the mesocolic fascia. (TNM clinical staging (cTNN) according to the 8th edition of AJCC/UICC guidelines); 3. No distant metastasis; 4. At least one measurable lesion ; 5. Immunohistochemical testing of endoscopic biopsy samples by the study center's pathology department confirms diagnosis as pMMR, or genetic testing confirms MSS/MSS-L status (by PCR or NGS method); 6. No prior anti-tumor treatment for colorectal cancer; 7. Age ≥18 years and ≤75 years, regardless of gender; 8. ECOG performance status score 0-1; 9. Signed written informed consent before enrollment; 10. Expected survival of more than 12 weeks;…
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