Cancer Nutritional, Metabolic, Endocrine
Conditions
Interventions
Placebo
SOSELIV1
SOSLIV2
Sponsors
Imo State University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following conditions are the necessary criteria required for inclusion in this study: - Drug naïve patients between 18 – 70 years with life expectancy between >6 months - Diagnosis of hepatocellular carcinoma (HCC) in line the American Association for the Study of Liver Diseases (AASLD) 2018 Guideline on Liver Cancer Diagnosis confirmed by postoperative pathology) - Barcelona Clinic Liver Cancer stage A and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 - Liver function Child-Pugh grade A with microvesicular invasion - Liver functions results showing: AST and ALT < 5× ULN, ALP < 4× ULN, serum albumin concentration = 30 g/L, and bilirubin = 50 umol/L. The platelet counts must also be = 75 × 109/L.
Exclusion criteria
Exclusion criteria: Meeting any of the below criteria leads to exclusion from the study - Any previous treatment for HCC - Pregnancy, lactation, or currently taking or scheduled for contraceptives within 1 year of this study - Participation in any other trial for HCC or any other cancer - Imaging examination showing macrovesicular invasion or diffuse infiltrative intrahepatic lesions - Failed R0 resection - Diagnosed of any immunodeficiency, non-infectious, or autoimmune disease that requires steroids, immunosuppressive therapies, administered within 2 weeks of study commencement. - Taking replacement therapies that does not provide systemic treatment - Any active infection, like HIV, syphilis, tuberculosis etc requiring systemic therapy - History of any other known malignancies or receiving allogeneic organ transplant. - Severe other organ dysfunctions or history or current evidence of abnormal lab results that may confound this clinical trial. - Any known allergy or mental illness that may affect the informed consent process or interfere with the completion of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of the study will be the Relapse-free survival (RFS) and the time to symptomatic progression (TTSP). The RFS will be assessed from the date of first intervention (DFI) until death regardless of cause. The TTSP will be measured from the DFI to first documented event of symptomatic progression. In this study, the magnitude of symptomatic progression will be defined as a decrease of at least 4 points, from the baseline score on patients’ responses to the FACT Hepatobiliary Symptom Index (FHSI) questionnaire, a deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) to 4, or death. Hypothesis: SOSLIV is superior to active surveillance in RFS of patients with HCC | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include overall survival for participants treated with SOSILIV vs those receiving active surveillance, Adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, deaths, laboratory values, and vital signs. | — |
Countries
Nigeria
Contacts
Public ContactPeter Amadi
University Lecturer
Outcome results
None listed