Can a smart drug starve liver tumors without harming healthy tissue?
NCT ID NCT04601428
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This trial tests a new biologic called CSR02-Fab-TF, given directly into the liver's blood supply, for people with intermediate or limited advanced liver cancer that has not responded to prior treatment. The drug is designed to block blood vessels that feed the tumor while sparing those in healthy liver tissue. The study aims to assess the safety and tolerability of different doses, and to see if it can reduce tumor blood flow and shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CSR02-Fab-TF, a laboratory-designed biologic that targets tumor blood vessels, given as an intra-arterial infusion
- What this could lead to
- If successful, this could lead to a more targeted treatment for liver cancer that spares healthy liver tissue, potentially improving outcomes for patients who have not responded to other therapies.
- What could go wrong
- This is an early-phase, dose-escalation study with only 12 participants, so safety and effectiveness are not yet established. The treatment may cause side effects or may not effectively shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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12 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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KFSYSCC
Taipei, 112, Taiwan
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Koo Foundation Sun Yat-Sen Cancer Center (KFSYSCC)
Taipei, Pei-Tou Dist., 11259, Taiwan
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National Cheng Kung University Hospital (NCKUH)
Tainan, North Dist., 70403, Taiwan
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National Taiwan University Hospital (NTUH)
Taipei, Zhongzheng Dist., 100225, Taiwan
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