AIM:To investigate the efficacy and safety of gemcitabine(Gem)-based combination chemotherapies for the treatment of advanced biliary tract cancer.METHODS:Clinical trials were identified by searching scientific literature databases(Pub Med,EMBASE and the Cochrane Library)for studies published between1975 and 2013.Two reviewers independently evaluated the relevant studies and manually searched references from these reports to locate additional eligible studies.The disease response and control rates,progressionfree and overall survivals,and the grade 3-4 toxicities were evaluated by a meta-analysis.Odds-ratios(ORs)of the disease response and control rates and grade3-4 toxicities,and the mean difference(MD)of both progression-free and overall survivals were calculated and used for statistical analysis.RESULTS:Seven randomized trials with a total of 858patients were selected and included in the final analysis.The studies were divided into subgroups based on the chemotherapy regimens,including Gem-based and non-Gem-based chemotherapies.The overall analyses revealed that the patients treated with Gem-based combination chemotherapy had significantly higher disease response rates[OR=1.69,95%confidence interval(CI):1.17-2.43;P=0.01],a longer progressionfree survival(MD=1.95,95%CI:0.90-3.00;P=0.00)and a longer overall survival(MD=1.85,95%CI:0.26-3.44;P=0.02).A higher incidence of grade 3-4hematological toxicities,including leukopenia(OR=2.98,95%CI:1.44-6.20;P=0.00),anemia(OR=2.96,95%CI:1.79-4.92;P=0.00)and neutropenia(OR=2.80,95%CI:1.39-5.64;P=0.00)was found in the Gem-based combination chemotherapy group compared with the Gem monotherapy and non-Gem-based chemotherapy groups.CONCLUSION:Gem-based combination chemotherapy is a potential first-line treatment for advanced biliary tract cancer as a result of improved survival,though with additional toxicity. AIM: To investigate the efficacy and safety of gemcitabine (Gem) -based combination chemotherapies for the treatment of advanced biliary tract cancer. METHODS: Clinical trials identified by searching scientific literature databases (Pub Med, EMBASE and the Cochrane Library) for studies published between1975 and 2013. Two reviewers independently evaluated the relevant studies and manually searched references from these reports to locate additional eligible studies.The disease response and control rates, progressionfree and overall survivals, and the grade 3-4 toxicities were evaluated by a meta-analysis . Odds-ratios (ORs) of the disease response and control rates and grade 3-4 toxicities, and the mean difference (MD) of both progression-free and overall survivals were calculated and used for statistical analysis .RESULTS: Seven randomized trials with a total of 858patients were selected and included in the final analysis.The studies were divided into subgroups based on the chemotherapy regimens, includ ing of Gem-based and non-Gem-based chemotherapies. The overall analysis revealed that the patients treated with Gem-based combination chemotherapy had significantly higher disease response rates [OR = 1.69, 95% confidence interval (CI): 1.17-2.43; P = 0.01] and a longer overall survival (MD = 1.95, 95% CI: 0.90-3.00; P = 0.00) incidence of grade 3-4hematological toxicities including leukopenia (OR = 2.98, 95% CI: 1.44-6.20; P = 0.00), anemia (OR = 2.96, 95% CI: 1.79-4.92; = 2.80, 95% CI: 1.39-5.64; P = 0.00) was found in the Gem-based combination chemotherapy group compared with the Gem monotherapy and non-Gem-based chemotherapy groups. CONCLUSION: Gem-based combination chemotherapy is a potential first -line treatment for advanced biliary tract cancer as a result of improved survival, though with additional toxicity.