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Search / Trial NCT04601428

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

Launched by KOO FOUNDATION SUN YAT-SEN CANCER CENTER · Oct 19, 2020

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Hepatocellular Carcinoma Hcc Hepatoma Ia (Intra Arterial) Therapy Plvap Csr02 Fab Tf

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a type of liver cancer called hepatocellular carcinoma (HCC) that is not suitable for surgery. The treatment being tested is called intra-arterial (IA) therapy, which works by targeting the blood supply that feeds the tumor. The goal is to cut off the tumor's blood supply and help it shrink or die, while minimizing effects on the surrounding healthy liver tissue. This trial is looking for adult patients who have been diagnosed with HCC and have not responded well to previous treatments.

To participate, patients need to be at least 18 years old, have specific types and stages of HCC, and meet certain health criteria, such as having an acceptable level of liver function and overall health. Participants can expect to receive careful monitoring during the treatment process. It's important to note that patients who have had certain recent treatments or have specific medical conditions may not be eligible. If you or someone you know is interested in learning more about this trial or thinks they might qualify, it's a good idea to talk to a healthcare provider for more information.

Gender

ALL

Eligibility criteria

  • 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

About Koo Foundation Sun Yat Sen Cancer Center

The Koo Foundation Sun Yat-sen Cancer Center is a leading research institution dedicated to advancing cancer treatment and prevention through innovative clinical trials and comprehensive patient care. Located in Taiwan, the center integrates cutting-edge scientific research with clinical expertise to develop effective therapies and improve patient outcomes. With a commitment to multidisciplinary collaboration, the Koo Foundation Sun Yat-sen Cancer Center aims to enhance the understanding of cancer biology and translate findings into meaningful clinical applications, contributing to global efforts in the fight against cancer.

Locations

Baltimore, Maryland, United States

Dallas, Texas, United States

Seattle, Washington, United States

Saint Louis, Missouri, United States

Tainan City, North Dist., Taiwan

Taipei, Pei Tou Dist., Taiwan

Taipei City, Zhongzheng Dist., Taiwan

Taipei, , Taiwan

Patients applied

0 patients applied

Trial Officials

Paul Weiden, M.D.

Study Director

KFSYSCC consultant

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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