Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases
A Phase II Clinical Study of Ivonescimab Plus CAPOX Regimen in Patients With Initially Unresectable Colorectal Cancer Liver-only Metastases
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate
Time frame: At the end of Cycle 8 (each cycle is 21 days)
Treatment-Emergent Adverse Events
Time frame: From the date of enrollment until 90 days after the Cycle 8 (each cycle is 21 days)
Secondary Endpoints
No evidence of disease rate
Progression-free survival
Overall Survival
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Histologically confirmed colorectal adenocarcinoma. 3. Radiologically confirmed liver-only metastases. Patients with ≤1 cm extrahepatic lesions not confirmed as metastatic are eligible. 4. No prior systemic therapy or local therapy for metastatic lesions, or completion of neoadjuvant/adjuvant chemotherapy ≥6 months before diagnosed disease recurrence. 5. Liver metastases considered unresectable or borderline resectable by multidisciplinary evaluation. 6. Liver metastases were measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 7. Eastern Cooperative Oncology Group performance status 0-1 8. Life expectancy ≥12 weeks. 9. No contraindications to hepatic resection/ablation, and primary tumor resectable or previously resected. 10. Adequate organ function as determined by normal bone marrow function (hemoglobin ≥80 g/L, absolute neutrophil count ≥1.5×10⁹/L, and platelets ≥100×10⁹/L), renal function (serum creati…
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