OncoMatch/Clinical Trials/NCT03812874
A Study of PTX-9908 Injection for Non-resectable HCC with TACE
Is NCT03812874 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies PTX-9908 for carcinoma, hepatocellular.
Treatment: PTX-9908 — This is a multicenter, Phase I/II study in patients with non-resectable hepatocellular carcinoma following TACE treatment. Phase I (Open-label dose escalation) This study will be an open-label study with an Accelerated Phase and a Standard Phase. For the Accelerated Phase of the study, one patient per dose level (1 mg/kg, and 2 mg/kg) is planned. For the dose levels in the standard phase (4 mg/kg, 8 mg/kg and 16 mg/kg), it will follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be followed by a 2-week follow-up period. Phase II (Randomized placebo controlled dose expansion) The objective of phase II is to further evaluate the safety, tolerability and antitumor activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma following TACE treatment. Approximately 24 eligible patients who have received TACE treatment and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays), and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed by a 2-week follow-up period.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC STAGE B (BCLC)
Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or Child-Pugh class A/B with large or multifocal HCC, no vascular invasion, or extrahepatic spread)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: transarterial chemoembolization
completed TACE procedure in 4 weeks before day 1 of study intervention infusion
Cannot have received: anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy (except in TACE regimen)
Patient who has had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy (except in TACE regimen) within 4 weeks prior to the screening visit
Cannot have received: investigational agents
Patient who has received any other investigational agents within 4 weeks prior to the screening visit
Lab requirements
Blood counts
Absolute neutrophil count > 1,200/µL; Hemoglobin > 9 g/dL; Platelets > 100,000/µL
Kidney function
eGFR > 60 mL/min/1.73m2
Liver function
ALT/AST and bilirubin within normal limit or reference numeric value (reference value is defined as the test value before TACE procedure); Total bilirubin < 2 X ULN
Cardiac function
No history of myocardial infarction or uncontrolled cardiac dysfunction, or unstable arrhythmia or symptomatic peripheral arterial vascular disease; No marked baseline prolongation of QT/QTc interval (>480 ms); No history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Recovered from TACE treatment and procedure related toxicities including ALT/AST and bilirubin within normal limit or reference numeric value... Absolute neutrophil count > 1,200/µL; Hemoglobin > 9 g/dL; Platelets > 100,000/µL; Total bilirubin < 2 X ULN; eGFR > 60 mL/min/1.73m2; history of myocardial infarction or uncontrolled cardiac dysfunction, or unstable arrhythmia or symptomatic peripheral arterial vascular disease; marked baseline prolongation of QT/QTc interval (>480 ms); history of additional risk factors for torsades de pointes
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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