Systemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab

NCT07192185 | Recruiting Phase 2 DMC

• 1 other identifier: FOLFOX+TA as 2nd treatment
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Atezolizumab plus bevacizumab is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, the effect of the second-line treatment after the progress of Atezolizumab plus bevacizumab therapy remains unsatisfactory. This is a prospective trial to investigate the efficacy and safety of systemic chemotherapy with FOLFOX plus Atezolizumab \& bevacizumab as second-line treatment for patients with advanced HCC who previously received atezolizumab plus bevacizumab

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

FOLFOX; Atezolizumab plus bevacizumab; Systemic chemotherapy

Outcome Measures

Primary Outcomes (1)

• ORR via mRECIST

  CR+PR via mRECIST

  12 months

Secondary Outcomes (3)

• OS

  12 months

• Progression Free Survival (PFS)

  12 months

• Adverse Events

  12 months

Study Arms (1)

FOLFOX+TA

EXPERIMENTAL

Systemic chemotherapy with FOLFOX plus Atezolizumab \& bevacizumab

Drug: FOLFOX; Drug: Atezolizumab & Bevacizumab

Interventions

FOLFOX DRUG

oxaliplatin 85mg/m2 + leucovorin 400mg/m2 + 5-fu 400mg/m2 + 5-fu 2400mg/m2 46h iv.drip Q3W

FOLFOX+TA

Atezolizumab & Bevacizumab DRUG

Atezolizumab 1200mg iv.drip + Bevacizumab 15mg/kg iv.drip Q3w

FOLFOX+TA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Folfox protocol; atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ming Shi

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Shi

CONTACT

8620-87343115; shiming@sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

CN (1)