SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial

This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care).

本研究为一项在美国开展的多中心、开放标签、随机双臂II期临床试验。拟纳入约210例符合入组标准的KRAS野生型（KRAS wild-type）转移性结直肠癌受试者，这些受试者既往接受一线含奥沙利铂化疗失败且至少完成4个周期含奥沙利铂化疗，同时接受过至少4个周期贝伐珠单抗（bevacizumab）治疗；治疗失败定义为含奥沙利铂方案化疗相关毒性，或一线治疗期间出现疾病进展。将按1:1比例随机分组，受试者将分别接受每两周一次（Q2W）FOLFIRI方案联合帕尼单抗（panitumumab）6mg/kg治疗，或每两周一次（Q2W）FOLFIRI方案联合贝伐珠单抗治疗（贝伐珠单抗剂量可选5mg/kg或10mg/kg，由主治医师根据临床选择及机构诊疗标准确定）。