Table 1.
Commonly used Terms in the Enrollment and Assessment of Clinical Trials for Hepatocellular Carcinoma (HCC)
| TERM | ACRONYM | DESCRIPTION |
|---|---|---|
| Clinical Trial Endpoints for Efficacy and Safety | ||
| Overall Survival | OS | Time between randomization in trial allocation until death, of any cause. |
| Progression Free Survival | PFS | Time from randomization until objective tumor progression or death, whichever occurs first. |
| Time to Progression | TTP | Time between trial allocation and radiological tumor progression. |
| Objective Response Rates | ORR | Percentage of patients who achieve an objective tumor response |
| Complete Response | CR | No detectable evidence of tumor |
| Quality of life | QOL | effect of the disease on an individual’s physical, psychological and social functioning and well-being |
| Common Terminology Criteria for Adverse Events | CTCAE | Criteria for the standardized classification of adverse events and lab abnormalities with cancer therapy. Grade refers to the severity of the AE. Grade of severity ranges from 1 to 5. In general, grade 1- asymptomatic or mild adverse events; 2- mild symptoms; 2- moderate symptoms; 3- severe symptoms; 4- life threatening consequences; 5- death due to adverse events |
| Staging HCC and Liver Disease for Clinical Trials | ||
| Barcelona Clinic Liver Cancer system | BCLC | Determines cancer stage and patient prognosis based on tumor burden, severity of liver disease, and the patient’s performance status. Stage 0- Very early stage; Stage A- Early; Stage B- Intermediate; Stage C- Advanced; Stage D- Terminal disease. |
| Child Pugh Class | CP class | Scale to assess severity of liver disease. Uses- severity of ascites and hepatic encephalopathy and blood tests (bilirubin, albumin, and prothrombin time). A CP score of 5–6 is class A (well-compensated); 7– 9 is class B (moderate severity); 10–15 is class C (decompensated disease). |
| Performance status | PS | The Eastern Cooperative Oncology Group (ECOG) criteria measures patient’s functional status- ability to perform self-care, activities of daily living and physical ability. |
| Response Evaluation Criteria in Solid Tumors | RECIST | Criteria to measure radiological response based on size (RECIST 1.1). Complete response (CR)- absence of all target lesions; partial response (PR) and progressive disease (PD) >30 % decrease and >20 % increase, respectively, in the sum of the longest diameters of the target lesions; and stable disease (SD), neither PR nor PD. Modified RECIST (mRECIST) criteria also includes evaluation of tumor viability or enhancement. |
The table defines major clinical trials endpoints and staging systems used in the enrollment for clinical trials evaluating systemic therapies for HCC.