FOLFOX chemotherapy with atezolizumab and bevacizumab after progression on atezolizumab plus bevacizumab for advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center Phase 2 trial testing whether systemic FOLFOX chemotherapy given together with continued atezolizumab and bevacizumab can control disease in patients with advanced hepatocellular carcinoma who progressed on prior atezolizumab plus bevacizumab. Eligible patients have BCLC stage C disease, Child-Pugh A liver function, ECOG performance status 0–2, at least one measurable lesion, and documented progression after first-line atezolizumab plus bevacizumab without intervening systemic therapy. Participants will receive combined FOLFOX with atezolizumab and bevacizumab and be followed for tumor response, safety, and survival outcomes. The study is led by Sun Yat-sen University Cancer Center in Guangzhou and uses imaging-based criteria to confirm progression and response.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Ming Shi — Sun Yat-sen University
• Study coordinator: Ming Shi
• Email: shiming@sysu.edu.cn
• Phone: 8620-87343115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.