A Study of PTX-9908 Injection for Non-resectable HCC with TACE
Recruiting
Phase 1
Phase 2
Interventional Study
Carcinoma, Hepatocellular
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 20 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- TCM Biotech International Corp. · Industry
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About This Trial
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/k…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 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) with completed TACE procedure in 4 weeks before day 1 of study intervention infusion.
2. Recov…
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