Clinical trial · Interventional
Efficacy and Safety Study of TLC388 to Advanced Hepatocellular Carcinoma
An Open-Label, Single-Arm, Two-Stage, Multi-Centre Phase II Study to Evaluate the Efficacy and Safety of TLC388 as Second-line Treatment in Subjects With Advanced Hepatocellular Carcinoma
NCT02267213CI-TRIAL-00037291terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Current study design couldn't support futher development on this indication
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of TLC388 (Lipotecan) as a second line treatment in subjects with advanced Hepatocellular Carcinoma.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lipotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lipotecan
- description
- Administer 40mg of Lipotecan at D1, D8, D15 of each cycles.
- interventionNames
- Drug: Lipotecan
Primary outcomes (1)
- measure
- Disease Control Rate (DCR)
- timeFrame
- 8 weeks from initial treatment
- description
- DCR (Disease control rate), the percentage of subjects with a best response rate of complete response (CR), partial response (PR), or stable disease (SD)
Secondary outcomes (13)
- measure
- Objective response rate (ORR; where ORR= CR rate + PR rate)
- timeFrame
- 8 weeks(Cycle 2), 16 weeks (Cycle 4), 24 weeks (Cycle 6) from initial treatment and/or Early termination (before 24 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Radiological diagnosis of hepatic tumor(s) by contrast-enhanced study * Subjects with advanced HCC who are not eligible for surgical resection or loco-regional therapy. * Subjects with sorafenib treatment failure due to sorafenib intolerance or radiographic PD (as per RECIST v1.1). Prior sorafenib use should be ≥ 400 mg/day for at least 14 days. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Child Pugh Score ≤ 6; * A life expectancy of at least 12 weeks or more Exclusion Criteria: * Subjects who have received any systemic target therapy or systemic chemotherapy other than sorafenib for the treatment of HCC. * Subjects who have received sorafenib within 2 weeks prior to the initiation of the treatment dose, or have any sorafenib-related toxicities not yet resolved to grade 1 or baseline. * Subjects who have undergone liver transplantation surgery. * Major surgery within 4 weeks prior to the initiation of the treatment dose (excluding implantation of the intravenous infusion device). Percutaneous liver puncture within 2 weeks prior to the initiation of the treatment dose.
References
Publications (0)
Data not yet available
No reference posted for this study.