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NCT Number: NCT07522411

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

FOLFOX regimen

Drug

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

Other names: HAIC

Immunotherapy

Drug

sintilimab (200 mg intravenous infusion, q3w)

Other names: sintilimab

targeted therapy

Drug

bevacizumab (15 mg/kg intravenous infusion, q3w)

Other names: bevacizumab

cTACE

Device

conventional transarterial chemoembolization

Primary outcomes

  1. 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

    2-year recurrence-free survival rate

Secondary outcomes

  1. pCR

    Time frame: Perioperative

    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.

  2. MPR

    Time frame: Perioperative

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

  3. ORR

    Time frame: Perioperative

    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

  4. R0 resection rate

    Time frame: Perioperative

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

  5. EFS

    Time frame: 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

BinYong Liang, M.D.

CONTACT

[email protected]

8615927271139

Sponsors and collaborators

Lead sponsor

BinYong Liang

Other

Collaborators

  • Beijing Bethune Charitable Foundation

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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