Multicenter phase 2 feasibility trial of neoadjuvant gemcitabine, cisplatin and nab-paclitaxel for high-risk intrahepatic cholangiocarcinoma

Most patients with intrahepatic cholangiocarcinoma (IHCC) develop recurrence after resection. A combination of gemcitabine, cisplatin, and nab-paclitaxel (GAP) was associated with a 45% response rate and 20% conversion rate among patients with unresectable biliary tract cancers. The multicenter phase 2 NEO-GAP trial evaluated the feasibility of neoadjuvant GAP for resectable, high-risk IHCC. Partial response was seen in 23% and stable disease in 67%. There was no treatment-related mortality. 73% of patients completed all chemotherapy and surgery. Median OS for the entire cohort was 24 months and was not reached among patients who underwent surgical resection. The authors conclude that neoadjuvant GAP is feasible and safe among patients with resectable, high-risk IHCC.