JPRN-jRCT2080221779
Unknown
Phase 2
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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Enrollment
- 185
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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