OncoMatch/Clinical Trials/NCT04601428
Hepatic IA Therapy in Stage B or Limited Stage C Hepatoma (HCC)
Is NCT04601428 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies IA therapy of HCC with CSR02-Fab-TF for hepatocellular carcinoma (hcc).
Treatment: IA therapy of HCC with CSR02-Fab-TF — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC INTERMEDIATE STAGE B, LIMITED ADVANCED STAGE C (BCLC)
Barcelona Clinic Liver Cancer (BCLC) Intermediate Stage B or limited Advanced Stage C
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: liver-directed therapy (TACE, bland embolization, Y90, ablation, radiation 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
Cannot have received: small molecule drug treatment for HCC (TACE)
Any small molecule drug treatment for HCC (including TACE) within the previous 30 days
Cannot have received: biological agents
treatment with biological agents or any investigational therapy within the previous 60 days
Cannot have received: Y90 (Y90)
treatment with Y90 within the previous 90 days
Lab requirements
Blood counts
Prothrombin time (INR) ≤ 1.5; Absolute neutrophil count > 1000/μL; Platelet count > 75,000/μL; Hgb > 8 g/dL
Kidney function
Serum creatinine ≤ 1.5 mg/dL
Liver function
Serum total bilirubin ≤ 2x ULN; Alkaline phosphatase, AST and ALT < 5 x ULN
Adequate laboratory parameters, including: Serum total bilirubin ≤ 2x ULN; Alkaline phosphatase, AST and ALT < 5 x ULN; Serum creatinine ≤ 1.5 mg/dL; Prothrombin time (INR) ≤ 1.5; Absolute neutrophil count > 1000/μL; Platelet count > 75,000/μL; Hgb > 8 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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