A Randomized, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients with Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 185 人开始时间: 2012年4月25日最近更新: 2023年10月17日

试验速览

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•Adult patients, >/= 18 years of age
•- Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)
•- Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or documented adverse event(s) associated with prior systemic agent(s) that resulted in discontinuance of that (those) agent(s)
•- Not a candidate for curative treatments (e.g. resection, transplantation)
•- Child-Pugh A (score of 5-6)
•- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•- Adequate hematologic, hepatic and renal function
•- Ability to provide, for central review, a tumor tissue sample to determine the level of GPC-3 expression by IHC
•- Measurable disease by RECIST 1.1

•- Child Pugh B or C
•- Known hepatocellular carcinoma with fibro-lamellar histology
•- Known brain or leptomeningeal metastases
•- Active infectious diseases requiring treatment except for hepatitis B and C
•- History of organ allograft including liver transplant
•- Anticipated or ongoing administration of anticancer therapies other than those administered in this study
•- Anticancer treatment within 2 weeks prior to entering the study
•- Patients who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies
•- Patients receiving interferon therapy
•- Pregnant or lactating women
•- Known HIV positivity or AIDS-related illness
•- History of hypersensitivity to similar agents (monoclonal antibody, protein-included drugs, Chinese hamster ovary products)

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