{"entity":{"id":"ascot-jcog1202","kind":"trial","name":"ASCOT (JCOG1202)","aka":["ASCOT","JCOG1202"],"tldr":"In Japan, six months of the oral chemotherapy S-1 after surgery for bile duct, gallbladder or ampullary cancer improved three-year survival from 68 to 77 percent. S-1 is not licensed for this use in the UK or Europe, so the result cannot be applied directly to NHS patients.","summary":"ASCOT (JCOG1202, UMIN000011688) randomised 440 patients between 2013 and 2018 (218 to S-1, 222 to observation) after resection of biliary tract cancer, including gallbladder carcinoma, with no or only microscopic residual tumour. S-1 (tegafur, gimeracil and oteracil) was given at 40 to 60 mg twice daily for four weeks of every six for four cycles. At a median follow-up of 45.4 months, three-year overall survival was 77.1 percent with S-1 versus 67.6 percent with observation (adjusted hazard ratio 0.69, 95 percent confidence interval 0.51 to 0.94, one-sided p 0.0080), meeting the primary endpoint; three-year relapse-free survival was 62.4 versus 50.9 percent (hazard ratio 0.80, 0.61 to 1.04). Grade 3 to 4 neutropenia occurred in 14 percent and biliary tract infection in 7 percent of the S-1 group. The trial makes S-1 the Japanese adjuvant standard alongside capecitabine from BILCAP; the two have not been compared. In Europe S-1 (Teysuno) is licensed only for gastric cancer, and it is not commissioned for biliary cancer in the UK, so capecitabine remains the NHS adjuvant drug. Gallbladder carcinoma was an eligible site and a stratification factor (primary tumour site), but a gallbladder-specific effect is not reported in the abstract.","status":"positive","asOf":"2026-09-24","links":[{"label":"Nakachi et al., Lancet 2023: adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT)","url":"https://doi.org/10.1016/S0140-6736(22)02038-4"},{"label":"UMIN000011688","url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013683"}],"tags":["registry:umin"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","extrahepatic-cholangiocarcinoma","intrahepatic-cholangiocarcinoma","ampullary","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["tegafur-gimeracil-oteracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registered with the UMIN Clinical Trials Registry as UMIN000011688; no ClinicalTrials.gov entry."],"phase":"3","setting":"Adjuvant S-1 for four cycles versus observation after resection of extrahepatic cholangiocarcinoma, gallbladder carcinoma, ampullary carcinoma or intrahepatic cholangiocarcinoma (R0 or R1), 38 Japanese hospitals","sponsor":"Japan Clinical Oncology Group","result":"3-year overall survival 77.1% vs 67.6%, adjusted HR 0.69 (0.51 to 0.94), one-sided p=0.0080.","yearReported":2023,"enrolled":440,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year overall survival","primary":true,"unit":"%","arms":[{"name":"S-1","n":218,"value":77.1},{"name":"Observation","n":222,"value":67.6}],"hr":0.69,"ci":[0.51,0.94],"p":"0.0080 (one-sided)","source":"https://doi.org/10.1016/S0140-6736(22)02038-4"},{"endpoint":"3-year relapse-free survival","unit":"%","arms":[{"name":"S-1","n":218,"value":62.4},{"name":"Observation","n":222,"value":50.9}],"hr":0.8,"ci":[0.61,1.04],"p":"0.088","source":"https://doi.org/10.1016/S0140-6736(22)02038-4"}]},"route":"/trials/ascot-jcog1202/","neighbours":{"cancer":[{"id":"ampullary","kind":"cancer","name":"Ampullary cancer (ampulla of Vater)","route":"/cancers/ampullary/"},{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"extrahepatic-cholangiocarcinoma","kind":"cancer","name":"Extrahepatic cholangiocarcinoma (perihilar and distal)","route":"/cancers/extrahepatic-cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"tegafur-gimeracil-oteracil","kind":"drug","name":"Tegafur, gimeracil and oteracil (S-1)","route":"/drugs/tegafur-gimeracil-oteracil/"}],"term":[{"id":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"}]}}