Clinical trial · Interventional
A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
A Single-arm, Open-label, Single-center Phase Ib Study to Evaluate the Safety and Efficacy of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Advanced Hepatocellular Carcinoma (HCC)
NCT04331743CI-TRIAL-00052298unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a dose escalation study based on 3+3 design with the aim to establish MTD and provide RP2D. PLM60 is to administered by multi-cycle intravenous infusion.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposome-entrapped Mitoxantrone Hydrochloride Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PLM60
- description
- Three dose levels will be tested according to the "3 + 3" dose-escalation design.The dose-limiting toxicity (DLT) will be assessed from the first administration of PLM60 to the end of the first cycle (28 days).
- interventionNames
- Drug: Liposome-entrapped Mitoxantrone Hydrochloride Injection
Primary outcomes (3)
- measure
- Dose-limited toxicity (DLT)
- timeFrame
- 1year
- description
- To identify the dose-limited toxicity (DLT).
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 1 year
- description
- To identify the maximum tolerated dose (MTD).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent from the patient; * ECOG performance status of 0 or 1; * Histologically/cytologically confirmed diagnosis of advanced HCC; * Adequate washout period for previous anti-tumor therapy; * Measurable disease according to RECIST v1.1; * Life expectancy ≥ 12 weeks; * Adequate organ function; * Child-Pugh grade A or partial grade B; BCLC stage B or C;V Exclusion Criteria: * Prior treatment with Mitoxantrone or Liposome-entrapped Mitoxantrone, or other anthracyclines, with the total cumulative dose of \> 360 mg/m2 ; * Any drug-related adverse event derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects, that has not recovered to grade1 or less; * Active central nervous system (CNS) metastases (brain or leptomeningeal metastases, etc.); * Any history of other malignancy within 5 years; * Untreated hepatitis infection; * HIV positive; * History of liver transplantation, severe cirrhosis, hepatic encephalopathy; * Inadequate cardiac function; * Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.