Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma (HCC)
ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKoo Foundation Sun Yat-Sen Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
IA therapy of HCC with CSR02-Fab-TF
Biological/VaccineIntra-Arterial Infusion of CSR02-Fab-TF
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: Investigational ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
Infusion to Day 502
HCC blood flow
HCC blood flow will be assessed by magnetic resonance imaging (MRI) on day 4 after infusion of CSR02-FabTF.
Time frame
MRI on Day 4Secondary outcomes
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.
Time frame
by MRI on Day 50 and then every 3 months for an average of one year.Sponsors and contacts
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Source ClinicalTrials.gov