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The German GAIN trial tried to test chemotherapy before the second operation for gallbladder cancer found by chance. It planned 333 patients but closed in October 2024 after enrolling 68, so it is unlikely to answer the question on its own.
GAIN (NCT03673072) was a multicentre, open-label randomised phase 3 run through the German Registry of Incidental Gallbladder Carcinoma with AIO, CALGP and ACO. Patients with incidental gallbladder carcinoma after simple cholecystectomy awaiting radical liver resection, or with resectable or borderline resectable intrahepatic or extrahepatic cholangiocarcinoma, were randomised to perioperative gemcitabine and cisplatin (three cycles before and three after surgery) or surgery alone followed by investigator's choice of therapy. The primary endpoint was overall survival with progression-free survival, R0 rate, toxicity, perioperative morbidity and quality of life as secondary endpoints, and 333 patients were planned. The registry lists the trial as completed on 10 October 2024 with an actual enrolment of 68, about a fifth of the target, at a single German site entry. No results were found in Europe PMC in September 2026. Together with OPT-IN it represents the only randomised attempt to move chemotherapy ahead of re-resection in incidental gallbladder cancer.
The rationale for OPT-IN and GAIN in one place. Until OPT-IN reports in 2028 the neoadjuvant approach for incidental cancer remains a reasoned choice rather than a proven one.
GAIN closed in October 2024 with 68 participants according to ClinicalTrials.gov, one fifth of its target: the clearest example of how hard it is to run a randomised surgical trial in incidental gallbladder cancer, and why OPT-IN's result matters.
Shares Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy, Gemcitabine + cisplatin, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Neoadjuvant / adjuvant / perioperative.
Shares Gemcitabine + cisplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine, Biliary tract cancer (cholangiocarcinoma).
Shares Gemcitabine + cisplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine, Biliary tract cancer (cholangiocarcinoma).
Shares Gemcitabine + cisplatin, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Neoadjuvant / adjuvant / perioperative, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Gemcitabine + cisplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine, Biliary tract cancer (cholangiocarcinoma).
Shares Gemcitabine + cisplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine, Biliary tract cancer (cholangiocarcinoma).
Shares Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine, Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.
Shares Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine, Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.