AIM:To evaluate the efficacy and safety of gemcitabine-oxaliplatin(GEMOX)cornbined with huachansu(cinobufagin)injection treatment in patients with locally advanced or metastatic gallbladder carcinoma(GBC),and to assess the quality of life(QOL)of such patients.METHODS:Twenty-five patients with locally advanced or metastatic GBC were treated with intravenous gemcitabine(1000 mg/m2)over 30 min on days 1 and 8,2 h infusion of oxaliplatin(120 mg/m2)on day 1,and 2-3 h infusion of huachansu(20 mL/m2)on days-3-11,every 3-4 wk.Treatment was continued until occurrence of unacceptable toxicity or disease progression.QOL of patients was assessed by the EORTC QLQ-C30 at baseline,at the end of the first,third and sixth chemotherapy cycles,and 1 mo after the treatment.RESULTS:Among the 25 patients with a median age of 64 years(range 42-78 years),23 were evaluable in the study.A total of 137 cycles of therapy were performed and the median cycle was 5(range 1-8)per patient.Out of the 23 patients whose response could be evaluated,8 partial responses(PR)were observed(34.8%),while 7 patients(30.4%)demonstrated a stable disease(SD).The disease control rate was 65.2%.Progression of cancer was observed in 8(34.8%)patients.The median progression-free and overall survival time was 5.8 mo(95% CI:4.5-7.1 mo)and 10.5 mo,respectively.The therapy was well tolerated,with moderate myelosuppression as the main toxicity.Anemia grade 2 was seen in 16.0%,neutropenia grade 3 in 8.0% and thrombocytopenia grade 3 in 24.0% of patients,respectively.Non-hematologic toxicity ranged from mild to moderate.No death occurred due to toxicity.The QOL of patients was improved after chemotherapy,and the scores of QOL were increased by 10 t0 20 points.CONCLUSION:GEMOX combined with huachansu(cinobufagin)injection is well tolerated,effective,thus ireproving the QOL of patients with advanced GBC.(C)2008 The WJG Press.All rights reserved.