Conditions: Carcinoma, Hepatocellular
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
The main purpose of this study is to determine if the advised dose of ramucirumab is safe to be taken with chemotherapy treatment in participants with advanced liver tumors.

Detailed description:

Arms:
arm 1: 8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:

FOLFOX4 every 2 weeks:

85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2

Participants may continue to receive treatment until discontinuation criteria are met.

Interventions: intervention 1: Ramucirumab intervention 2: FOLFOX4
Intervention descriptions: intervention 1: Administered IV. intervention 2: Administered IV.

Protocol document: