JPRN-jRCT2080222919
Completed
Phase 3
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib
ConditionsHepatocellular Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Eli Lilly Japan K.K.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A diagnosis of HCC based on histopathologic findings, or a diagnosis of cirrhosis and a tumor with classical HCC imaging characteristics.
- •\-Prior sorafenib treatment for at least 14 days and discontinuation of sorafenib more than or equal14 days prior to randomization.
- •\-Radiographic disease progression during or after sorafenib therapy or discontinuation of sorafenib because of intolerance.
- •\-Sorafenib was the only systemic therapy for HCC.
- •\-More than or equal1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1\.1 that has not been previously treated with locoregional therapy.
- •\-Child\-Pugh score less than 7 (Child\-Pugh Class A).
- •\-Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy.
- •\-Baseline AFP more than or equal 400 nanograms/milliliter.
- •\-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\.
- •\-Resolution of all clinically significant toxic effects of prior therapy.
Exclusion Criteria
- •\-Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- •\-Concurrent malignancy. Participants with carcinoma in situ of any origin and participants with prior malignancies in remission may be eligible with sponsor approval.
- •\-Previous brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
- •\-History of or current hepatic encephalopathy or clinically meaningful ascites.
- •\-Ongoing or recent hepatorenal syndrome.
- •\-Liver transplant.
- •\-Previous systemic therapy with vascular endothelial growth factor (VEGF) pathway inhibitors other than sorafenib for treatment of HCC.
- •\-Hepatic locoregional therapy following sorafenib or within 28 days prior to randomization.
- •\-Major surgical procedure, traumatic injury, non\-healing wound, or peptic ulcer less than or equal 28 days prior to randomization.
- •\-Placement of a subcutaneous venous access device within 7 days prior to the first dose of study treatment unless the procedure is judged of low risk of bleeding.
Outcomes
Primary Outcomes
Not specified
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