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: 待定

适应症

试验速览

暂无简介。

•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)

Progression-free survival tumor assessments according to RECIST criteria

未报告次要终点

发起方