A Study of PTX-9908 Injection for Non-resectable HCC with TACE

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 intra

Trial Details

NCT ID
NCT03812874
Phase
PHASE1 / PHASE2
Sponsor
TCM Biotech International Corp.
Status
RECRUITING
Cancer Type
Hepatocellular Carcinoma (HCC) Liver Cancer
Interventions
  • PTX-9908 Injection
  • Placebo
Locations (sample)
  • New Taipei City, Taiwan, Taiwan

Key Eligibility Criteria

  • Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or Child-Pugh class A/B with large or multifocal HCC, no vascular…
  • Recovered from TACE treatment and procedure related toxicities including ALT/AST and bilirubin within normal limit or reference numeric value (refe…
  • ECOG (Eastern Cooperative Oncology Group) performance status \< 2.
  • Have adequate organ and marrow function as defined below:

For full eligibility, visit ClinicalTrials.gov.

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