FOLFOX chemotherapy with atezolizumab and bevacizumab after progression on atezolizumab plus bevacizumab for advanced liver cancer
Systemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab: a Single Arm Trial.
This trial will test whether giving FOLFOX chemotherapy together with continued atezolizumab and bevacizumab helps people with advanced hepatocellular carcinoma whose cancer progressed on prior atezolizumab plus bevacizumab.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07192185 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced HCC (BCLC-C) who progressed on first-line atezolizumab plus bevacizumab, have Child-Pugh A liver function, ECOG 0–2, measurable disease, and no prior systemic therapies other than atezolizumab plus bevacizumab.
Not a fit: Patients with poorer liver function (Child-Pugh B or C), those who received other systemic treatments after progression, people eligible for curative local therapies, or those with ECOG >2 are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could improve tumor control and extend survival for patients who have progressed on first-line atezolizumab plus bevacizumab.
How similar studies have performed: FOLFOX has shown activity in HCC and atezolizumab plus bevacizumab is established first-line therapy, but continuing atezolizumab/bevacizumab together with FOLFOX after progression is a relatively novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.