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Hepatocellular Carcinoma (HCC)Early Phase 1NCT04601428

Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma (HCC)

A Early Phase 1 study testing IA therapy of HCC with CSR02-Fab-TF in people with Hepatocellular Carcinoma (HCC), run by Koo Foundation Sun Yat-Sen Cancer Center at 4 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Intra-arterial (IA) therapy is generally used to treat HCC tumors that are too extensive to excise or treat with potentially curative local therapy. IA therapy takes advantage of the fact that the blood supply of HCC comes predominantly from the hepatic artery compared with the surrounding normal liver which is… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
IA therapy of HCC with CSR02-Fab-TF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesTaiwan
Study dates
26 Jan 2021to 9 Apr 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Diagnosis of HCC by at least one of the following criteria:
  • Histological confirmation;
  • Magnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 1 cm with intense contrast uptake during the arterial phase followed by contrast washout during the venous phase regardless of alpha-fetal protein (AFP) level
  • Barcelona Clinic Liver Cancer (BCLC) Intermediate Stage B or limited Advanced Stage C (see Protocol Section 3.1). Patients with Stage C disease should have received or been offered and chosen not to receive systemic therapy
  • Inadequate response to prior liver-directed therapy (e.g., TACE, bland embolization, Y90, ablation, radiation therapy) to the same targeted area or progressive disease after prior liver-directed therapy) or to one or more systemic therapies
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  • Not a candidate for curative resection, liver transplantation, or percutaneous ablation (See Protocol Appendix 3)
  • Eastern Collective Oncology Group (ECOG) performance status ≤1 (See Protocol Appendix 5)
  • Adequate laboratory parameters, including:
  • Serum total bilirubin ≤ 2x ULN
  • Alkaline phosphatase, aspartate aminotransferase (AST) and aspartate aminotransferase (ALT) < 5 x ULN;
  • Serum creatinine ≤ 1.5 mg/dL;
  • Prothrombin time (international normalized ratio; INR) ≤ 1.5;
  • Absolute neutrophil count > 1000/μL;
  • Platelet count > 75,000/μL;
  • Hgb > 8 g/dL
  • Acceptable pulmonary status, including room air O2 saturation > 90%
  • Child-Pugh A-B7 without clinically significant ascites (See Protocol Appendix 4)
  • Signed informed consent
  • All subjects must be surgically sterile, at least two years post-menopausal (if female), or agree to use adequate, effective contraception approved by the Investigator until two (2) months after receiving a final dose of CSR02-Fab-TF

Who cannot join

  • Eligible for transplantation by Milan criteria (Protocol Appendix 3) or potentially eligible if successfully "down staged" by pre-transplant therapy
  • Prior organ transplantation
  • Any small molecule drug treatment for HCC (including TACE) within the previous 30 days, treatment with biological agents or any investigational therapy within the previous 60 days, or treatment with Y90 within the previous 90 days.
  • Previously treated malignancies from which the subject has not been disease-free for at least 2 years, except for adequately treated non-melanoma skin cancer, in situ cancer, or low-grade prostate or bladder cancer
  • Severe chronic obstructive or other pulmonary disease with hypoxemia that requires supplementary oxygen or clinically significant pleural effusions
  • New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 3 months prior to therapy, unstable arrhythmia, symptomatic peripheral arterial vascular disease, or presence of an artificial or other vascular device requiring chronic anticoagulation (See Protocol Appendix 6)
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  • Any of the following risks related to QT/QTc interval:
  • Baseline prolongation of QT/QTc interval (repeated interval > 480 milliseconds using Frederica's QT correction formula);
  • History of additional risk factors for Torsades de Pointes (e.g. heart failure, hypokalemia, family history of Long QT syndrome);
  • Concomitant medications that have a known risk for prolongation of the QT/QTc interval (see https://crediblemeds.org/new-drug-list/)
  • Major surgery, vascular injury, or serious illness within the previous 60 days
  • Known inherited thrombophilia (hypercoagulable state) or history of unprovoked venous or arterial thrombosis
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy at screening. Subjects with prior HBV (positive HBSAg) must have HBV viral load < 2000 IU/mL or be receiving concurrent anti-HBV therapy to be eligible. Subjects on anti-HBV therapy must have been on treatment with a viral load maintained at < 2000 IU/mL for at least 4 weeks prior to first dose and continue on this same therapy throughout study treatment. Subjects with HCV infection are eligible if other eligibility criteria are met
  • Females who are breast-feeding
  • Allergy to iodinated contrast medium that is uncontrolled or refractory to medical therapy
  • Therapeutic anticoagulation that cannot be stopped 24-72 hours before treatment (per Section 4.5) and reinstituted no sooner than 72 hours after therapy
  • Any concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study
  • Unwillingness or inability to comply with the study protocol for any reason

Trial locations and contacts

4 sites in 1 country.

Taiwan4 sites

  • National Cheng Kung University Hospital (NCKUH)

    Tainan, North Dist., 70403

  • Koo Foundation Sun Yat-Sen Cancer Center (KFSYSCC)

    Taipei, Pei-Tou Dist., 11259

  • National Taiwan University Hospital (NTUH)

    Taipei, Zhongzheng Dist., 100225

  • KFSYSCC

    Taipei, 112

Other trials in Taiwan

About this study

Official title: CSR02-Fab-TF as Hepatic Intra-arterial Therapy in Intermediate Stage B or Limited Advanced Stage C Hepatocellular Carcinoma (HCC): Dose-Escalation Study to Assess Safety and Tolerability

Intra-arterial (IA) therapy is generally used to treat HCC tumors that are too extensive to excise or treat with potentially curative local therapy. IA therapy takes advantage of the fact that the blood supply of HCC comes predominantly from the hepatic artery compared with the surrounding normal liver which is predominantly supplied by portal venous blood. The intent is to deprive the HCC of its blood supply, leading to the death of the tumor. Traditionally, various methods have been used to block the HCC blood supply, but improvements are needed. This study will investigate a new agent designed in the laboratory to block only tumor blood vessels, not blood vessels in the normal liver.

Read the detailed description

Genetic testing was done to identify differences between HCC tumors and normal liver, and a protein, PLVAP, was shown to be present on the blood vessels of HCC but not on the blood vessels of normal liver. An antibody, CSR02, was made that recognizes PLVAP and then the Fab portion of that antibody was combined with tissue factor, a normal human protein that initiates the clotting cascade. The result is a manufactured (recombinant) protein called CSR02-Fab-TF. Preclinical studies in a mouse model showed that infusion of an equivalent mouse protein resulted in the necrosis (death) of a transplanted human HCC. The current study is designed first, to identify a safe and optimal dose of CSR02-Fab-TF in patients , and then second, to determine the response rate of HCC tumors to the IA administration of CSR02-Fab-TF.

Being tested
IA therapy of HCC with CSR02-Fab-TF
Keywords
Hepatocellular carcinoma, HCC, hepatoma, IA (intra-arterial) therapy, PLVAP, CSR02-Fab-TF
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • IA therapy of HCC with CSR02-Fab-TFBiological

    Intra-Arterial Infusion of CSR02-Fab-TF

Study groups in NCT04601428
Study groupRoleWhat they receive
Investigational ArmExperimentalNot described
Receives: Biological: IA therapy of HCC with CSR02-Fab-TF

What is being measured

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

  1. Incidence and severity of adverse events from intra-arterial infusion of CSR02-Fab-TF in patients with hepatoma only or largely confined to the liver, and resistant/recurrent after prior therapy

    Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: Infusion to Day 50

  2. HCC blood flow

    HCC blood flow will be assessed by magnetic resonance imaging (MRI) on day 4 after infusion of CSR02-FabTF.

    Measured: MRI on Day 4

Secondary outcomes (1)

  1. Determine tumor response to intra-arterial infusion of CSR02-Fab-TF

    Measured by radiographic response using acceptable imaging modalities used for assessment of tumor vasculature and blood flow (MRI or CT) based on mRECIST.

    Measured: by MRI on Day 50 and then every 3 months for an average of one year.

Timeline

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

  1. First posted23 Oct 2020
  2. Study start26 Jan 2021
  3. Primary completion9 Apr 2026
  4. Study completion9 Apr 2026

Why it stopped: The decision has been made to terminate the study due to logistical reasons and not due to any safety concerns.

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The dose escalation phase of the study will begin with 3 single cohort subjects and then proceed to a traditional 3 +3 study design until a Maximum Tolerated Dose (MTD) or an active dose (i.e., a dose at which subjects achieve a complete response in the liver or complete elimination of tumor blood flow) is identified. Once an appropriate dose in established, an expansion phase will administer CSR02-Fab-TF to 16 additional subjects to estimate the response proportion in subjects with refractory HCC.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04601428
Sponsor's protocol ID
KF-CSR02-001
Status last verified
Aug 2026
First submitted
29 Sep 2020
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Forner A, Gilabert M, Bruix J, Raoul JL. Treatment of intermediate-stage hepatocellular carcinoma. Nat Rev Clin Oncol. 2014 Sep;11(9):525-35. doi: 10.1038/nrclinonc.2014.122. Epub 2014 Aug 5.

    PubMed 25091611

  • Wang YH, Cheng TY, Chen TY, Chang KM, Chuang VP, Kao KJ. Plasmalemmal Vesicle Associated Protein (PLVAP) as a therapeutic target for treatment of hepatocellular carcinoma. BMC Cancer. 2014 Nov 6;14:815. doi: 10.1186/1471-2407-14-815.

    PubMed 25376302

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing IA therapy of HCC with CSR02-Fab-TF in people with Hepatocellular Carcinoma (HCC), run by Koo Foundation Sun Yat-Sen Cancer Center at 4 sites in Taiwan.

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 20 inclusion and 18 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: stopped early, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Taiwan. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The decision has been made to terminate the study due to logistical reasons and not due to any safety concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events from intra-arterial infusion of CSR02-Fab-TF in patients with hepatoma only or largely confined to the liver, and resistant/recurrent after prior therapy (time frame: Infusion to Day 50). The study lists 2 primary outcomes in all. 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 NCT04601428, which also lists 2 linked publications.

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 Aug 2026.

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