Perioperative chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone in gallbladder carcinoma or in front of radical resection in BTC: The phase III GAIN trial.

Abstract

TPS353 Background: Radical surgical resection represents the only potentially curative treatment option for Biliary Tract Cancer (BTC) and Gallbladder Carcinoma (GBC). Nevertheless, 5-year OS is only 20–40% after curatively intended resection. GBC is the fifth most common neoplasm of the digestive tract and even the most frequent cancer of the biliary system. The majority of gallbladder carcinoma cases are discovered incidentally by the pathologist after cholecystectomy for a benign indication, so called incidental gallbladder carcinomas. For improving curative rates in BTC and GBC, early systemic therapy combined with radical resection seems to be a promising approach. The earliest moment to apply chemotherapy would be in front of radical surgery. Encouraging results of neoadjuvant/perioperative concepts in other malignancies provide an additional rationale to use this treatment in the early phase management of GBC and intrahepatic as well extrahepatic cholangiocarcinoma, especially because data regarding pure adjuvant chemotherapy in BTC`s are currently conflicting. Methods: GAIN is a multicenter, randomized, controlled, open-label phase III trial, including pts with GBCs in front of radical liver resection and pts with resectable/borderline resectable intra- and extrahepatic cholangiocarcinomas (ICC/ECC). Pts. are randomized to either neoadjuvant systemic chemotherapy (Gemcitabine + Cisplatin 3 cycles pre- and post-surgery) followed by radical surgery or to direct surgery without neoadjuvant treatment. Primary endpoint is OS; secondary endpoints are PFS, R0-resection rate, toxicity, perioperative morbidity, mortality and QoL. A total of N = 333 patients with GBC or BTC will be included. Recruitment has just started; first patient in was on December 6th, 2019. Clinical trial information: NCT03673072.