{"entity":{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","aka":[],"tldr":"Gemcitabine plus cisplatin has been the chemotherapy backbone for bile duct cancer since 2010 and is now given with immunotherapy.","summary":"Gemcitabine, a nucleoside analogue that terminates DNA chains, is combined with cisplatin, which crosslinks DNA, giving two complementary attacks on dividing cells. The doublet has been the chemotherapy backbone for advanced biliary tract cancer since ABC-02 (2010) showed overall survival of 11.7 versus 8.1 months against gemcitabine alone (HR 0.64), and it is given on days 1 and 8 of a 3-week cycle for up to 8 cycles. It is now the backbone of TOPAZ-1 with durvalumab (OS HR 0.76, 24-month OS 23.6% versus 11.5%) and KEYNOTE-966 with pembrolizumab (OS 12.7 versus 10.9 months), so most patients receive it with immunotherapy. Adding nab-paclitaxel (SWOG 1815) did not improve survival. Grade 3 to 4 neutropenia (25%) and fatigue are the main toxicities, and renal function and hearing need monitoring. For a newcomer, this is the standard two-drug chemotherapy for bile duct cancer.","status":"standard-of-care","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Gemcitabine","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Gemcitabine"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","cup-unfavourable","locoregionally-advanced-nasopharyngeal-carcinoma","recurrent-metastatic-nasopharyngeal-carcinoma","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["abc-02","topaz-1","keynote-966","nct05771480","nct06109779","nct02453282","nct02542293","nct03003962","nct06225596","nct07221253","nct06591520","acticca-1","swog-s1815","opt-in","polcagb","gain-igbc","rugb","debate","eortc-1607-pembro-cisgem","abc-07","abc-12","ea2197-ivonescimab","trap-btc","gap-phase2-mdacc","nife"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: the doublet is the backbone for gallbladder cancer as for cholangiocarcinoma. In TOPAZ-1 25 percent of patients had gallbladder cancer (Imfinzi label), in SWOG S1815 16 percent, and in the 60-patient phase 2 that preceded S1815 22 percent; the adjuvant ACTICCA-1 trial randomised a separate muscle-invasive gallbladder cohort to 24 weeks of the doublet, and the perioperative OPT-IN, GAIN and POLCAGB trials use it before radical surgery."],"modality":"Cytotoxic regimen","mechanism":"Nucleoside analogue (gemcitabine) plus DNA crosslinker (cisplatin).","approvals":[],"mechanismSteps":[],"dosing":{"route":"Intravenous","schedule":"Gemcitabine 1000 mg/m² + cisplatin 25 mg/m² days 1 and 8 every 3 weeks, up to 8 cycles","monitoring":"Renal function, hearing, blood counts"},"toxicity":[{"event":"Neutropenia (grade 3-4)","grade3PlusPct":25,"note":"ABC-02"},{"event":"Fatigue","grade3PlusPct":19,"note":"ABC-02"}],"access":[],"regulatoryEvents":[]},"route":"/drugs/gemcitabine-cisplatin/","neighbours":{"cancer":[{"id":"gallbladder-adenosquamous-squamous-carcinoma","kind":"cancer","name":"Adenosquamous and squamous carcinoma of the gallbladder","route":"/cancers/gallbladder-adenosquamous-squamous-carcinoma/"},{"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":"brca-palb2-pdac","kind":"cancer","name":"BRCA or PALB2-mutant pancreatic ductal adenocarcinoma","route":"/cancers/brca-palb2-pdac/"},{"id":"cancer-of-unknown-primary","kind":"cancer","name":"Cancer of unknown primary (CUP)","route":"/cancers/cancer-of-unknown-primary/"},{"id":"cup-unfavourable","kind":"cancer","name":"Cancer of unknown primary, unfavourable (adenocarcinoma and poorly differentiated carcinoma)","route":"/cancers/cup-unfavourable/"},{"id":"collecting-duct-carcinoma","kind":"cancer","name":"Collecting duct carcinoma of the kidney","route":"/cancers/collecting-duct-carcinoma/"},{"id":"cystic-duct-carcinoma","kind":"cancer","name":"Cystic duct carcinoma","route":"/cancers/cystic-duct-carcinoma/"},{"id":"extrahepatic-cholangiocarcinoma","kind":"cancer","name":"Extrahepatic cholangiocarcinoma (perihilar and distal)","route":"/cancers/extrahepatic-cholangiocarcinoma/"},{"id":"gallbladder-adenocarcinoma","kind":"cancer","name":"Gallbladder adenocarcinoma","route":"/cancers/gallbladder-adenocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"incidental-gallbladder-cancer","kind":"cancer","name":"Incidental gallbladder cancer (found after cholecystectomy)","route":"/cancers/incidental-gallbladder-cancer/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"},{"id":"locoregionally-advanced-nasopharyngeal-carcinoma","kind":"cancer","name":"Locoregionally advanced nasopharyngeal carcinoma (stage III to IVA)","route":"/cancers/locoregionally-advanced-nasopharyngeal-carcinoma/"},{"id":"gallbladder-mucinous-carcinoma","kind":"cancer","name":"Mucinous carcinoma of the gallbladder","route":"/cancers/gallbladder-mucinous-carcinoma/"},{"id":"nasopharyngeal","kind":"cancer","name":"Nasopharyngeal carcinoma","route":"/cancers/nasopharyngeal/"},{"id":"recurrent-metastatic-nasopharyngeal-carcinoma","kind":"cancer","name":"Recurrent and metastatic nasopharyngeal carcinoma","route":"/cancers/recurrent-metastatic-nasopharyngeal-carcinoma/"},{"id":"urethral","kind":"cancer","name":"Urethral cancer","route":"/cancers/urethral/"},{"id":"urethral-urothelial-carcinoma","kind":"cancer","name":"Urothelial carcinoma of the urethra","route":"/cancers/urethral-urothelial-carcinoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"trial":[{"id":"nct07221253","kind":"trial","name":"A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)","route":"/trials/nct07221253/"},{"id":"abc-02","kind":"trial","name":"ABC-02","route":"/trials/abc-02/"},{"id":"abc-07","kind":"trial","name":"ABC-07","route":"/trials/abc-07/"},{"id":"abc-12","kind":"trial","name":"ABC-12","route":"/trials/abc-12/"},{"id":"acticca-1","kind":"trial","name":"ACTICCA-1","route":"/trials/acticca-1/"},{"id":"nct06591520","kind":"trial","name":"AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer","route":"/trials/nct06591520/"},{"id":"captain-1st","kind":"trial","name":"CAPTAIN-1st","route":"/trials/captain-1st/"},{"id":"debate","kind":"trial","name":"DEBATE","route":"/trials/debate/"},{"id":"nct05771480","kind":"trial","name":"Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)","route":"/trials/nct05771480/"},{"id":"ea2197-ivonescimab","kind":"trial","name":"EA2197 ivonescimab: ivonescimab with gemcitabine and cisplatin versus standard chemo-immunotherapy in advanced biliary tract cancer","route":"/trials/ea2197-ivonescimab/"},{"id":"eortc-1607-pembro-cisgem","kind":"trial","name":"EORTC 1607: pembrolizumab with cisplatin and gemcitabine in biliary tract cancer","route":"/trials/eortc-1607-pembro-cisgem/"},{"id":"fight-302","kind":"trial","name":"FIGHT-302","route":"/trials/fight-302/"},{"id":"gain-igbc","kind":"trial","name":"GAIN (AIO/CALGP/ACO)","route":"/trials/gain-igbc/"},{"id":"gap-phase2-mdacc","kind":"trial","name":"Gemcitabine, cisplatin and nab-paclitaxel phase 2 (MD Anderson and Mayo)","route":"/trials/gap-phase2-mdacc/"},{"id":"herizon-btc-302","kind":"trial","name":"HERIZON-BTC-302","route":"/trials/herizon-btc-302/"},{"id":"keynote-966","kind":"trial","name":"KEYNOTE-966","route":"/trials/keynote-966/"},{"id":"nife","kind":"trial","name":"NIFE (AIO-YMO HEP-0315)","route":"/trials/nife/"},{"id":"opt-in","kind":"trial","name":"OPT-IN (EA2197)","route":"/trials/opt-in/"},{"id":"nct02453282","kind":"trial","name":"Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)","route":"/trials/nct02453282/"},{"id":"polcagb","kind":"trial","name":"POLCAGB","route":"/trials/polcagb/"},{"id":"nct06109779","kind":"trial","name":"Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)","route":"/trials/nct06109779/"},{"id":"rugb","kind":"trial","name":"RUGB","route":"/trials/rugb/"},{"id":"safir-abc10","kind":"trial","name":"SAFIR-ABC10","route":"/trials/safir-abc10/"},{"id":"nct06225596","kind":"trial","name":"Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)","route":"/trials/nct06225596/"},{"id":"nct03003962","kind":"trial","name":"Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)","route":"/trials/nct03003962/"},{"id":"nct02542293","kind":"trial","name":"Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) 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