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ABC-02 was the 2010 UK trial that gave bile duct cancer its first standard chemotherapy: 410 patients with advanced biliary tract cancer were randomised to gemcitabine plus cisplatin or gemcitabine alone, and the doublet lengthened life and delayed progression. It stayed the control arm for every first-line trial for more than a decade.
ABC-02, sponsored by Cancer Research UK and reported in the New England Journal of Medicine in 2010, was the UK trial that gave bile duct cancer its first standard chemotherapy, gemcitabine plus cisplatin. It randomised 410 patients with locally advanced or metastatic biliary tract cancer to the doublet or gemcitabine alone, met its primary overall survival endpoint and delayed progression, and remained the control arm for every subsequent first-line trial for more than a decade. OnCo links it to biliary tract and gallbladder cancer, the gemcitabine plus cisplatin record, Cancer Research UK and Juan W. Valle, and the result was confirmed by the Japanese BT22 trial. Whether triplet chemotherapy or immunotherapy additions, as in TOPAZ-1, now make the doublet alone obsolete is the question that followed.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
410 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Gemcitabine + cisplatin | 204 | 11.7 months | 0.64 (0.52 to 0.8) | <0.001 | link |
| Gemcitabine | 206 | 8.1 months |
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares John Bridgewater, Juan W. Valle, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).