AzTrials
AzTrials

Hepatocellular CarcinomaPhase 1/2NCT07522411

Sequential FOLFOX-HAIC-TACE Plus Sintilimab-Bevacizumab Neoadjuvant Therapy Versus Direct Resection in Resectable High-Risk Recurrence Hepatocellular Carcinoma

A Phase 1/2 study testing FOLFOX regimen, Immunotherapy and targeted therapy in people with Hepatocellular Carcinoma, run by BinYong Liang.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is designed to evaluate the efficacy and safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE as the perioperative adjuvant therapy in surgical resection to hepatocellular carcinoma with high-risk features. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
FOLFOX regimen, Immunotherapy and targeted therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
30 Apr 2026to Feb 2028
Phase
Phase 1/2
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

  • 1.Fully understanding and voluntarily signing the informed consent form, complying with the requirements and evaluation schedule of this study; 2.18 to 75 years old; 3.Hepatocellular carcinoma diagnosed by histopathology; 4.Imaging examination results meeting the definition of high-risk recurrence risk factors in this study: 2-4 multiple tumors; the size of the dominant tumor was >=5 cm; CNLC-Ⅲa incorporated with portal vein tumor thrombus [Vp1/2/3]; 5.Surgical evalution with a radically resectable tumor; 6.Child-Pugh class A; 7.ECOG PS： 0~1; 8.hepatocellular carcinoma who had never received previous form of systemic therapy; 9.At least one measurable lesion that can be accurately assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for assessment per mRECIST 1.1; 10.The main organ functions are normal, including the following criteria: (1) sufficient bone marrow function, defined as neutrophils ≥ 1.5 × 10 ^ 9/L, hemoglobin (Hb) ≥ 90 g/dL, platelets ≥ 50 × 10 ^ 9/L; (2) good liver function, defined as serum total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN, albumin ≥ 28 g/L; (3) good coagulation function, defined as international normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the normal control range ≤ 3 seconds; (4) Adequate renal function， defined as glomerular filtration rate (GFR)>90mL/min; 11.Female participants of childbearing potential have negative results on a pregancy test in 3 days before the first utilization of medicine and male or female participants with partners of child-bearing potential had to use a medically acceptable method of contraception through 180 days after taking study drug

Who cannot join

  • Pregnant or lactating women;
  • Patients with a history of other malignancies within the past 5 years, excluding basal cell carcinoma of the skin， cervical carcinoma in situ and/or thyroid papillary carcinoma have been cured;
  • Patients who are known to be allergic to the trial drugs, finolizumab and bevacizumab；
  • Previous history of upper gastrointestinal bleeding or current presence of a clear bleeding risk disease;
  • Patients with uncontrolled cardiac clinical symptoms or diseases；
  • Uncontrolled cardiac symptoms or diseases, including but not limited to (1) heart failure above NYHA class II, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically important significant supraventricular or ventricular arrhythmias requiring clinical intervention；
Show all 11Show fewer
  • Patients with any active autoimmune disease or history of autoimmune disease；
  • Have a history of immune deficiency, including HIV-positive test results, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and bone marrow transplantation;
  • History of mental illness, and abuse of psychiatric drugs and narcotics;
  • Severe uncontrolled recurrent infections or other serious uncontrolled concomitant diseases;
  • Situations that researchers assessed as unsuitable for inclusion in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

BinYong Liang, M.D. contact

8615927271139

Binyong.liang@tjh.tjmu.edu.cn

About this study

Official title: Efficacy and Safety of Sequential FOLFOX-HAIC Followed by TACE Combined With Sintilimab Plus Bevacizumab as Neoadjuvant Therapy, Followed by Surgical Resection, Versus Direct Surgical Resection in Patients With Resectable Hepatocellular Carcinoma and High-Risk Recurrence Factors: A Single-Center, Open-Label, Two-Arm, Randomized Study

This study is designed to evaluate the efficacy and safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE as the perioperative adjuvant therapy in surgical resection to hepatocellular carcinoma with high-risk features. (1) Evaluate for some high-risk patients with resectable tumours, whether or not sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE reduces the risk of recurrence and improves the survival of patients. (2) Evaluate the safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE for the neoadjuvant therapy of resectable hepatocellular carcinoma.

Being tested
FOLFOX regimen, Immunotherapy, targeted therapy, cTACE
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFOX regimenDrug

    Also called HAIC

    oxaliplatin 85 mg/m² intra-arterial infusion over 2 hours; leucovorin calcium 200 mg/m² intra-arterial infusion over 2 hours; 5-fluorouracil 400 mg/m² intra-arterial bolus followed by 2400 mg/m² continuous intra-arterial infusion over 46 hours

  • ImmunotherapyDrug

    Also called sintilimab

    sintilimab (200 mg intravenous infusion, q3w)

  • targeted therapyDrug

    Also called bevacizumab

    bevacizumab (15 mg/kg intravenous infusion, q3w)

  • cTACEDevice

    conventional transarterial chemoembolization

Study groups in NCT07522411
Study groupRoleWhat they receive
Group A（ Intervention group)Experimental2-4 cycles of quadruple therapy (3 weeks per cycle) consisting of neoadjuvant FOLFOX-HAIC (oxaliplatin 85 mg/m² intra-arterial infusion over 2 hours; leucovorin calcium 200 mg/m² intra-arterial infusion over 2 hours; 5-fluorouracil 400 mg/m² intra-arterial bolus followed by 2400 mg/m² continuous intra-arterial infusion over 46 hours) sequentially combined with cTACE, sintilimab (200 mg intravenous infusion, q3w) and bevacizumab (15 mg/kg intravenous infusion, q3w). Tumor response was evaluated every 2 cycles, and radical resection was performed based on assessment results. After radical hepatectomy, patients continued to receive sintilimab plus bevacizumab for 8 cycles within 4-12 weeks postoperatively.
Receives: Drug: FOLFOX regimen; Drug: Immunotherapy; Drug: targeted therapy; Device: cTACE
Group B ( Control group)Otherhepatectomy, and sintilimab was administered for 8 cycles with in 4 to 12 weeks after hepatectomy
Receives: Drug: Immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2y-RFS

    2-year recurrence-free survival rate

    Measured: From date of randomization until date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 2 years

Secondary outcomes (5)

  1. pCR

    pathological Complete Response，defined as the absence of residual invasive tumor cells in the primary tumor and regional lymph nodes in the resected specimen after neoadjuvant therapy.

    Measured: Perioperative

  2. MPR

    Major Pathological Response，presence of viable tumor cells ≤30% in the primary tumor and lymph nodes after radical resection

    Measured: Perioperative

  3. ORR

    Objective Response Rate，the proportion of patients who achieved complete response (CR) or partial response (PR) in tumor shrinkage according to the mRECIST v1.1 criteria and maintained the response for at least 8 weeks

    Measured: Perioperative

  4. R0 resection rate

    The proportion of patients who achieved radical R0 resection among those who underwent surgery.

    Measured: Perioperative

  5. EFS

    Event-Free Survival, defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding surgery, local or distant recurrence, or death from any cause.

    Measured: the time from randomization to the first occurrence of any of the following events: disease progression precluding surgery, local or distant recurrence, or death from any cause，assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07522411
Sponsor's protocol ID
GDZL032
Status last verified
Apr 2026
First submitted
26 Mar 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FOLFOX regimen, Immunotherapy and targeted therapy in people with Hepatocellular Carcinoma, run by BinYong Liang.

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 1 inclusion and 11 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 BinYong Liang, M.D. (8615927271139, Binyong.liang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2y-RFS (time frame: From date of randomization until date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07522411.

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 13 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in