← Back to results
NCT06790212PHASE2NOT_YET_RECRUITING

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.

Request endpoint coverage

Key Facts

Study type
INTERVENTIONAL
Conditions
Colon Cancer
Interventions
Ivonescimab, Oxaliplatin, Capecitabine
Enrollment
168 participants
Primary completion
Aug 2027
Study completion
Jun 2028
First posted
Jan 2025
Last updated
Mar 2025

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;

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Request coverage →

Source

Open on ClinicalTrials.gov