Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC) - a phase III study of the German registry of incidental gallbladder carcinoma platform (GR)- the AIO/ CALGP/ ACO- GAIN-trial

Protocol for GAIN, a multicentre randomised open-label phase 3 built on the German Registry of Incidental Gallbladder Carcinoma. Patients with incidentally discovered gallbladder cancer before radical re-resection, or with resectable or borderline resectable cholangiocarcinoma, were to receive three cycles of gemcitabine plus cisplatin before and after surgery, or surgery alone followed by therapy of the investigator's choice. Primary endpoint overall survival; planned 333 patients; recruitment started August 2019. The authors note that gallbladder cancer is suspected before surgery in only about 30 percent of patients and that five-year survival after curative resection is 20 to 40 percent.