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NCT07021950PHASE2NOT_YET_RECRUITING

AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer

Ivonescimab (AK112) Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer: a Randomized, Controlled, Multicenter Phase II Study

Sponsor: Sun Yat-sen University

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Colorectal Cancer, Ivonescimab
Interventions
AK112, FOLFIRI, Bevacizumab
Enrollment
130 participants
Primary completion
Oct 2027
Study completion
Dec 2028
First posted
Jun 2025
Last updated
Jun 2025

Primary Endpoints (CT.gov)

PFS

Time frame: up to 24 months

Secondary Endpoints

ORR

DCR

DoR

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily sign written informed consent 2. Agree to provide tumor and blood samples for biomarker detection 3. Age ≥18 and ≤75 years at enrollment, regardless of gender 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 5. Expected survival ≥3 months 6. Pathologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma 7. Confirmed MSS/pMMR-type CRC by immunohistochemistry (IHC), PCR, or NGS 8. Intolerance to oxaliplatin-containing standard first-line therapy, disease progression, or recurrence within \< 6 months after oxaliplatin adjuvant therapy 9. Adequate organ function (last 14 days without intervention): 1. Absolute neutrophil count (ANC) ≥1.5×10⁹/L without granulocyte colony-stimulating factor1. 2. Platelets ≥100×10⁹/L without transfusion1. 3. Hemoglobin \>9 g/dL without transfusion or erythropoietin1. 4. Total bilirubin ≤1.5×ULN1. 5. AST/ALT ≤2.5×ULN1. 6. Serum creatinine ≤1.5×

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✦ Analyst Commentary

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

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Source

Open on ClinicalTrials.gov