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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

HAIC Combined with Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)

Sintilimab Plus Bevacizumab Biosimilar with or Without HAIC for Advanced Hepatocellular Carcinoma (TASK-03): a Multicenter, Randomized, Phase 2 Study

HAIC Combined with Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03) (NCT06860490) is a Phase 2 interventional studying Hepatocellular Carcinoma (HCC), sponsored by Fudan University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hepatocellular Carcinoma (HCC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 164 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hepatocellular Carcinoma (HCC) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Written willing to sign a consent form obtained. - Age ≥ 18 years at time of study entry. - Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies. - HCC confirmed by radiology, histology or cytology. - No previous cancer treatment that works throughout the body (like chemotherapy) for HCC. - At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI. - Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale). - Subjects with chronic HBV infection must have HBV DNA viral load \< 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. - expected to live at least 12 weeks. - Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelet count at least 60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula) - Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. - Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up. Who Should NOT Join This Trial: - Patients on a liver transplantation list or with advanced liver disease. - History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Written informed consent obtained. * Age ≥ 18 years at time of study entry. * Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies. * HCC confirmed by radiology, histology or cytology. * No prior systemic therapy for HCC. * At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI. * Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale). * Subjects with chronic HBV infection must have HBV DNA viral load \< 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. * Life expectancy of at least 12 weeks. * Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula) * Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. * Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up. Exclusion Criteria: * Patients on a liver transplantation list or with advanced liver disease. * History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment * Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein. * Prior systemic anti-cancer therapy OR endocrine- OR immunotherapy. * Prior treatment with HAIC. * Radiotherapy administered less than 4 weeks prior to study treatment start. * Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery. * Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix. * Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV). * Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer. * Previous treatment in the present study (does not include screening failure). * Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to: a) history of interstitial lung disease b) Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) c) known acute or chronic pancreatitis d) active tuberculosis e) any other active infection (viral, fungal or bacterial) requiring systemic therapy f) history of allogeneic tissue/solid organ transplant g) diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. h) Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study. i) Live vaccine within 30 days prior to the first dose of treatment or during study treatment. j) History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS. * Medication that is known to interfere with any of the agents applied in the trial. * Any other efficacious cancer treatment except protocol specified treatment at study start. * Patient has received any other investigational product within 28 days of study entry. * Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). * Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening. * Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Treatments Being Tested

DRUG

Sintilimab

Sintilimab will be administered by IV, 200 mg on day 1 of each 21 day cycle.

DRUG

Bevacizumab Biosimilar

Bevacizumab biosimilar will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle.

PROCEDURE

HAIC

FOLFOX regimen (oxaliplatin, 85 mg/m2 from hour 0-2 on day 1; leucovorin, 400 mg/m2 from hour 2-3 on day 1; and fluorouracil, 400 mg/m2 bolus at hour 3 on day 1 and 2,400 mg/m2 over 24 hours) via infusion via the hepatic artery. HAIC was repeated once every 3 weeks for up to four cycles. Sintilimab plus bevacizumab will be administered 1-3 days after HAIC.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06860490), the sponsor (Fudan University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06860490 clinical trial studying?

To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06860490?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06860490?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06860490. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06860490. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.