Hepatocellular Carcinoma (HCC)Phase 2NCT07192185
Systemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab
A Phase 2 study testing FOLFOX and Atezolizumab & Bevacizumab in people with Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- FOLFOX and Atezolizumab & Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2025to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Ming Shi, 8620-87343115, shiming@sysu.edu.cn
About this study
Official title: Systemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab: a Single Arm Trial.
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)
- Being tested
- FOLFOX, Atezolizumab & Bevacizumab
- Keywords
- FOLFOX, Atezolizumab plus bevacizumab, Systemic chemotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXDrug
oxaliplatin 85mg/m2 + leucovorin 400mg/m2 + 5-fu 400mg/m2 + 5-fu 2400mg/m2 46h iv.drip Q3W
Atezolizumab & BevacizumabDrug
Atezolizumab 1200mg iv.drip + Bevacizumab 15mg/kg iv.drip Q3w
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX+TA | Experimental | Systemic chemotherapy with FOLFOX plus Atezolizumab \& bevacizumab Receives: Drug: FOLFOX; Drug: Atezolizumab & Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR via mRECIST
CR+PR via mRECIST
Measured: 12 months
Secondary outcomes (3)
OS
overall survival was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Measured: 12 months
Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Measured: 12 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start17 Sep 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
- Investigators
- Ming Shi, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192185
- Sponsor's protocol ID
- FOLFOX+TA as 2nd treatment
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab: a Single Arm Trial.
- ClinicalTrials.gov ID
- NCT07192185
- Acronym / sponsor ID
- FOLFOX+TA as 2nd treatment
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- FOLFOX, Atezolizumab plus bevacizumab, Systemic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOX+TA | Experimental | Drug: FOLFOX, Drug: Atezolizumab & BevacizumabSystemic chemotherapy with FOLFOX plus Atezolizumab \& bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOXoxaliplatin 85mg/m2 + leucovorin 400mg/m2 + 5-fu 400mg/m2 + 5-fu 2400mg/m2 46h iv.drip Q3W | Drug | FOLFOX+TA |
| Atezolizumab & BevacizumabAtezolizumab 1200mg iv.drip + Bevacizumab 15mg/kg iv.drip Q3w | Drug | FOLFOX+TA |
Primary outcome
ORR via mRECIST
Time frame: 12 months
CR+PR via mRECIST
3 secondary outcomes
OS
Time frame: 12 months
Progression Free Survival (PFS)
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming Shi principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX and Atezolizumab & Bevacizumab in people with Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Shi (8620-87343115, shiming@sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR via mRECIST (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.