{"entity":{"id":"neolap","kind":"trial","name":"NEOLAP","aka":["NEOLAP-AIO-PAK-0113","AIO-PAK-0113"],"tldr":"NEOLAP asked whether switching to FOLFIRINOX after two months of gemcitabine and nab-paclitaxel converts more inoperable pancreatic cancers to operable ones; about a third to 44 percent were removed with either sequence and survival was similar, so both induction regimens are acceptable.","summary":"NEOLAP randomised 130 of 168 registered patients (64 to continued nab-paclitaxel plus gemcitabine, 66 to sequential FOLFIRINOX) between November 2014 and April 2018. Surgical exploration was done in 63 and 64 percent; complete macroscopic resection in 23 and 29 patients, a conversion rate of 35.9 percent (95 percent confidence interval 24.3 to 48.9) against 43.9 percent (31.7 to 56.7) (odds ratio 0.72; p 0.38). Median overall survival was 18.5 months against 20.7 months (hazard ratio 0.86; p 0.53), with better histopathological downstaging after FOLFIRINOX (ypT1/2 in 69 against 17 percent). Grade 3 or worse events during induction occurred in 55 and 53 percent, including bile duct obstruction with cholangitis in 9 and 11 percent. The trial underpins the corpus's locally advanced row: four to six months of multi-agent induction, surgical exploration for responders, and no proven advantage of one backbone over the other.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02125136","url":"https://clinicaltrials.gov/study/NCT02125136"},{"label":"Kunzmann et al., NEOLAP (Lancet Gastroenterology and Hepatology 2021)","url":"https://doi.org/10.1016/S2468-1253(20)30330-7"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine-nab-paclitaxel","folfirinox"],"companies":["aio"],"institutions":[],"pathways":[],"terms":["resectability","acute-cholangitis"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02125136","phase":"2","setting":"Treatment-naive locally advanced pancreatic adenocarcinoma at 28 German centres: after two cycles of nab-paclitaxel plus gemcitabine, two further cycles of the same against four cycles of FOLFIRINOX, all followed by surgical exploration, with the surgical conversion rate as the primary endpoint","sponsor":"AIO-Studien-gGmbH (German pancreatic cancer group), with Celgene","result":"Surgical conversion 35.9 percent with continued nab-paclitaxel plus gemcitabine against 43.9 percent with sequential FOLFIRINOX (odds ratio 0.72; p 0.38); median overall survival 18.5 against 20.7 months (hazard ratio 0.86; p 0.53).","yearReported":2021,"enrolled":130,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT02125136 lists an estimated 168 participants; 168 were registered and 130 without progression after two cycles of nab-paclitaxel plus gemcitabine were randomised according to the Lancet Gastroenterology and Hepatology 2021 report.","outcomes":[{"endpoint":"Surgical conversion rate (complete macroscopic resection)","primary":true,"unit":"%","arms":[{"name":"Nab-paclitaxel + gemcitabine x4","n":64,"value":35.9,"note":"95% CI 24.3 to 48.9"},{"name":"Nab-paclitaxel + gemcitabine x2 then FOLFIRINOX x4","n":66,"value":43.9,"note":"95% CI 31.7 to 56.7"}],"p":"0.38","source":"https://doi.org/10.1016/S2468-1253(20)30330-7"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Nab-paclitaxel + gemcitabine x4","value":18.5},{"name":"Nab-paclitaxel + gemcitabine x2 then FOLFIRINOX x4","value":20.7}],"hr":0.86,"ci":[0.55,1.36],"p":"0.53","source":"https://doi.org/10.1016/S2468-1253(20)30330-7"}]},"route":"/trials/neolap/","neighbours":{"cancer":[{"id":"locally-advanced-pdac","kind":"cancer","name":"Locally advanced unresectable pancreatic ductal adenocarcinoma","route":"/cancers/locally-advanced-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"folfirinox","kind":"drug","name":"FOLFIRINOX / mFOLFIRINOX","route":"/drugs/folfirinox/"},{"id":"gemcitabine-nab-paclitaxel","kind":"drug","name":"Gemcitabine + nab-paclitaxel","route":"/drugs/gemcitabine-nab-paclitaxel/"},{"id":"nab-paclitaxel","kind":"drug","name":"Nab-paclitaxel","route":"/drugs/nab-paclitaxel/"}],"company":[{"id":"aio","kind":"company","name":"AIO (Arbeitsgemeinschaft Internistische Onkologie)","route":"/companies/aio/"}],"term":[{"id":"acute-cholangitis","kind":"term","name":"Cholangitis: infection of a blocked bile duct","route":"/terms/acute-cholangitis/"},{"id":"resectability","kind":"term","name":"Resectable, borderline resectable and unresectable","route":"/terms/resectability/"}]}}