Recruiting

FOLFOX, Atezolizumab, and Bevacizumab for Advanced Hepatocellular Carcinoma

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What is being tested

FOLFOX

+ Atezolizumab & Bevacizumab

Drug
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorSun Yat-sen University
Study ContactMing Shi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleSystemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab: a Single Arm Trial.
NCT07192185
Principal SponsorSun Yat-sen University
Study ContactMing Shi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Systemic chemotherapy with FOLFOX plus Atezolizumab \& bevacizumab

Study 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

Recruiting

Sun Yat-sen University Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google Maps
Recruiting
One Study Center