BACKGROUND/AIMS: @entity1 with advanced unresectable @entity189 have a dismal prognosis. The efficacy of systemic chemotherapy in these @entity1 is negligible and often, in particular in @entity1 with @entity157 , the @entity137 of chemotherapy outweighs the potential palliative effect of antineoplastic agents. @entity136 is a new anticancer agent with a mild @entity137 profile, which has demonstrated antineoplastic activity in many solid @entity5 . Therefore we investigated the effect of @entity136 in @entity1 with advanced nonresectable hepatocellular and @entity201 in a phase II study. METHODOLOGY: Twenty-three @entity1 with @entity201 and 20 @entity1 with @entity157 were enrolled into the study. Eighteen of the 20 @entity1 with @entity157 had @entity1575 . @entity136 was administered once weekly over 30 min for 3 consecutive weeks out of every 4 weeks. @entity1 with @entity201 received @entity136 also in the forth week of the first cycle with no rest to the following cycle. Disease status was assessed every 4 weeks. RESULTS: Overall the regimen was well tolerated. The median number of @entity136 administration was 15 (range, 3-37) in the group of @entity1 with @entity201 and 7.6 (range, 3-21) in the group of @entity1 with @entity157 . In the group of @entity1 with @entity157 @entity882 was the most frequent side effect (30% grade 3/4). Among the @entity1 with @entity201 nausea and @entity1398 were the most commonly observed side effects. The overall response rate of @entity157 was only 5% and chemotherapy generally did not improve the @entity5 symptoms of the @entity1 in this group. In contrast, in the group of @entity201 , seven @entity1 achieved a partial response (overall response rate 30%). Eleven @entity1 with @entity201 revealed @entity5 symptoms before the onset of @entity136 treatment. Seven of these @entity1 developed a treatment related clinical benefit as defined as a relief of @entity5 symptoms or gain of weight. CONCLUSIONS: Our results indicate that the treatment of @entity201 with @entity136 is effective and should be further evaluated in phase III studies. In contrast, palliative chemotherapy with @entity136 cannot be recommended in @entity1 with @entity157 and @entity1575 .

Phase II study of systemic @entity136 chemotherapy for advanced unresectable XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'tumors'] @entity189 :: ('MESH:D002277', 'Disease') :: ['hepatobiliary carcinomas'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity201 :: ('MESH:D018281', 'Disease') :: ['cholangiocarcinomas', 'cholangiocellular carcinomas', 'cholangiocellular carcinoma'] @entity1575 :: ('MESH:D008103', 'Disease') :: ['liver cirrhosis'] @entity157 :: ('MESH:D006528', 'Disease') :: ['hepatocellular carcinoma', 'hepatocellular carcinomas'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['Gemcitabine', 'gemcitabine']
@entity189 :: (MESH:D002277,Disease) :: ['hepatobiliary carcinomas']
