RecruitingPhase 2NCT07192185

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

Systemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab: a Single Arm Trial.


Sponsor

Sun Yat-sen University

Enrollment

30 participants

Start Date

Sep 17, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

  • 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 Criteria8

  • 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

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Interventions

DRUGFOLFOX

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

DRUGAtezolizumab & Bevacizumab

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


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07192185


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