FOLFOX, Atezolizumab, and Bevacizumab for Advanced Hepatocellular Carcinoma
FOLFOX
+ Atezolizumab & Bevacizumab
Adenocarcinoma+8
+ Carcinoma
+ Digestive System Diseases
Treatment Study
Summary
Study start date: September 17, 2025
Actual date on which the first participant was enrolled.This study is focused on finding a better way to treat patients with advanced hepatocellular carcinoma (HCC), a type of liver cancer, who have already tried and not had success with a treatment combination of atezolizumab and bevacizumab. The research aims to see if adding a chemotherapy regimen called FOLFOX to the existing atezolizumab and bevacizumab can offer a more effective second-line treatment option. With current options not delivering satisfactory results, this study could potentially improve outcomes for patients battling this challenging condition. Participants in this study will receive the FOLFOX chemotherapy regimen along with atezolizumab and bevacizumab. The treatment is administered systemically, meaning it affects the whole body, and is given through an intravenous method, which involves injection into the veins. The study will evaluate how well this combination works and will also monitor the safety of this approach. By assessing the effectiveness and safety, the study aims to provide insights that could lead to improved treatment strategies for patients with advanced liver cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. * Barcelona clinic liver cancer-stage C * Patients who have previously received first-line treatment with atezolizumab plus bevacizumab and who have shown tumor progression as confirmed by imaging studies. No other systemic treatments have been administered. * Eastern Cooperative Oncology Group performance status of 0 to 2 * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * The following laboratory parameters: Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 • Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Sun Yat-sen University Cancer Center
Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google Maps