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New treatment option for Hepatocellular Carcinoma (HCC)
Official title Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma (HCC)
ClinicalTrials.gov ID: NCT04601428
What this study is testing
What is IA therapy of HCC with CSR02-Fab-TF?
IA therapy of HCC with CSR02-Fab-TF is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Barcelona Clinic Liver Cancer (BCLC) Intermediate Stage B or limited Advanced Stage C (see Protocol Section 3.1). Patients with Stage C disease...
You likely can't join if
- 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...
- Previously treated malignancies from which the subject has not been disease-free for at least 2 years, except for adequately treated non-melanoma...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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 people 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...
- 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...
- 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...
- 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. people with prior HBV (positive HBSAg) must have HBV viral load \< 2000 IU/mL or be receiving concurrent anti-HBV...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tainan, North Dist., Taiwan
- Taipei, Pei-Tou Dist., Taiwan
- Taipei, Zhongzheng Dist., Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tainan, North Dist., Taiwan; Taipei, Pei-Tou Dist., Taiwan; Taipei, Zhongzheng Dist., Taiwan; Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.