The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma

The time from first day of therapy to the first date of objective evidence of progressive disease (PD) by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is defined as having at least a 20% increase in sum of longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of new lesion. Time to PD is censored at the date of death or study discontinuation.

Overall survival (OS) is the duration from first dose to death due to any cause. OS is censored at last contact date for participants who are alive at the end of follow-up period or lost to follow-up.

Objective response rate (ORR) is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). As classified according to Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR is the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions. PR is having at least a 30% decrease in sum of longest diameter of target lesions.

Duration of response is the interval from the date of initial documented response [complete response (CR) , partial response (PR) or Stable disease] to the first documented date of disease progression, initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR is the disappearance of all target lesions, PR is having at least a 30% decrease in the sum of the longest diameter of target lesions, and stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data are censored for participants who did not progress or die.

Tumor necrosis is quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area is measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation without contrast enhance in tumor after TACE is regarded as an indication of necrosis. Tumor necrosis is assessed at Baseline and 1-3 days prior to the next scheduled transarterial chemoembolisation (TACE) till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.

The iron of liver will be measured by MRI, where R2* and QSM is applied to present the quantity of iron. Iron reduction is assessed at Baseline and 1-3 days prior to the next scheduled transarterial chemoembolisation. The test will be repeated 1 -3 days after the therapy. The reduction of liver iron will be calculated accordingly.

The iron of liver will be measured by MRI, where R2* and QSM is applied to present the quantity of iron. All patients will undergo MRI before TACE, and the test will be repeated 1 -3 days after the therapy till disease progression. The reduction of liver iron will be calculated accordingly. Based on the measurements mentioned above, the prognostic value of reduction of liver iron will be analyzed.

Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that are considered by the investigator to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.