title: A phase II clinical trial with cytotropic heterogeneous molecular lipids (CHML) for patients with hepatic malignancies.
abstract: Hepatocellular carcinoma (HCC) and other forms of metastatic liver cancer (MLC) have poor outcomes due to the limited treatment options. Surgery, radiotherapy and chemotherapy have a limited success. Thus, there is an urgent need for novel therapies for patients with advanced HCC and MLC. The response and toxicity profile of a novel biological anticancer agent, cytotropic heterogeneous molecular lipids (CHML), in 135 Asian patients with hepatic malignancies treated at five different hospitals in China from April 1998 to August 2003 is described. This trial included 97 patients with HCC and 38 with MLC. The majority of these patients had received conventional therapies and many had failed to respond or relapsed. CHML was administered by intra-arterial (i.a.) infusion with or without simultaneous intravenous (i.v.) infusion for 25 days with a rest of 2-4 weeks between each cycle. Fifty three percent of patients received two cycles, and 47% received three cycles. The complete response (CR) rates were 23% for HCC and 29% for MLC with an overall CR of 24%. The overall partial response (PR) was 53%. The patients with earlier stages and limited tumor burden had a better response, but a few patients with advanced disease also achieved PR. The patients who achieved CR or PR had a significant increase in long-term survival for up to five years. The treatment with CHML resulted in minimal toxicity and the reported adverse reactions were not higher than grade II. CHML is an effective therapy for hepatic malignancies, showing responses and increases in survival in patients in whom other therapies have failed. CHML is well tolerated and is an excellent candidate for Phase III clinical trials.
authors.affiliation: Huashan Hospital, Fudan University, Shanghai 200040, China.
authors.forename: Xian-Cheng
authors.initials: XC
authors.lastname: Chen
authors.forename: Bo
authors.initials: B
authors.lastname: Yu
authors.forename: Jing-Cheng
authors.initials: JC
authors.lastname: Dong
authors.forename: Yu-Xiang
authors.initials: YX
authors.lastname: Gu
authors.forename: Lei
authors.initials: L
authors.lastname: Chen
authors.forename: Qing-Zhen
authors.initials: QZ
authors.lastname: Wu
authors.forename: Nan-Ping
authors.initials: NP
authors.lastname: Hou
authors.forename: Jun-Xiong
authors.initials: JX
authors.lastname: Liu
authors.forename: Jia-Ting
authors.initials: JT
authors.lastname: Xu
authors.forename: Rui-Xie
authors.initials: RX
authors.lastname: Jin
authors.forename: Guan-Qiu
authors.initials: GQ
authors.lastname: Jin
authors.forename: Xue-Dong
authors.initials: XD
authors.lastname: Yang
authors.forename: Yong-Wei
authors.initials: YW
authors.lastname: Cao
authors.forename: Jia-Ju
authors.initials: JJ
authors.lastname: Tan
authors.forename: Bin
authors.initials: B
authors.lastname: Zhu
authors.forename: Jia-Chuan
authors.initials: JC
authors.lastname: Shen
authors.forename: Zheng
authors.initials: Z
authors.lastname: Xu
authors.forename: Lyuba
authors.initials: L
authors.lastname: Varticovski
authors.forename: Xin Wei
authors.initials: XW
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000556:secondary; D005231:Fatty Acids, Unsaturated / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011859:Radiography; D013534:Survival; D016896:Treatment Outcome
chemical_list: D005231:Fatty Acids, Unsaturated; C403743:cytotropic heterogeneous molecular lipid