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OPT-IN is the American trial asking whether people whose gallbladder cancer was found by chance should have chemotherapy before their second operation or only after it. It is the first randomised test of neoadjuvant treatment in incidental gallbladder cancer and will report overall survival.
OPT-IN (ECOG-ACRIN EA2197, NCT04559139) is a randomised phase 2/3 trial for patients with histologically confirmed T2 or T3 gallbladder cancer discovered incidentally at or after routine cholecystectomy for presumed benign disease, without disseminated disease. Patients are randomised to neoadjuvant gemcitabine and cisplatin followed by re-resection (partial hepatectomy of the gallbladder bed with portal lymphadenectomy) and further chemotherapy, or to immediate re-resection followed by adjuvant chemotherapy. The primary endpoint is the difference in overall survival; 186 patients are planned across 367 US sites, the trial opened in February 2021, is active but no longer recruiting, and lists primary completion in July 2028. It is the only randomised trial dedicated to incidental gallbladder cancer still running after the German GAIN trial closed early, and its result will decide whether the 4 to 8 week window before re-resection should be filled with chemotherapy.
Shares Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy, Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Hepatectomy (liver resection).
Shares Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy, Incidental gallbladder cancer (found after cholecystectomy), Gemcitabine + cisplatin, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares A national incidental gallbladder cancer pathway: histology for every gallbladder, referral within two weeks, re-resection by eight, Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares A national incidental gallbladder cancer pathway: histology for every gallbladder, referral within two weeks, re-resection by eight, Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy, Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Hepatectomy (liver resection).
Shares A national incidental gallbladder cancer pathway: histology for every gallbladder, referral within two weeks, re-resection by eight, Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Lymphadenectomy (lymph node dissection), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
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).