A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)

未提供0 个研究点目标入组 50 人开始时间: 待定

适应症

试验速览

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•An Eastern Cooperative Oncology Organization Group (ECOG) performance status score of 0 or
•Expected life expectancy is at least 6 months.
•Patients with histologically or cytologically confirmed metastatic CRC, not amenable to curative resection.
•No prior systemic therapy for metastatic CRC.
•At least one measurable tumor lesion according to RECIST v1.1 that is amenable to repeated accurate measurements.

•Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
•Known BRAF V600E mutant status
•Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction.
•Ascites requiring paracentesis within last 30 days.
•Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and any other therapy based on the mechanism of action of tumor immunity or angiogenesis.
•Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
•Resectable oligometastastic only disease, with multidisciplinary plan for complete resection of all disease.

发起方

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