Clinical trial · Interventional
A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
- 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)
Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in patient who is not suitable for transarterial chemoembolization (TACE) and other local therapy, especially in those with portal vein tumor thrombosis (PVTT) caused by tumor cells. Several previous studies have showed that local R/T is tolerable and can induce a substantial tumor response in HCC management. In addition, the safety, toxicity and preliminary efficacy of Lipotecan® (TLC388) has also been proved in patients with terminal malignancy. This study aims to evaluate the safety, tolerability and efficacy of concomitant Lipotecan® and radiotherapy in patients with locally advanced HCC and PVTT.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lipotecan® (TLC388) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lipotecan® (TLC388)
- description
- Dosage form: 40mg TLC388 base/vial lyophilized cake Dose: Chemotherapy, i.v. q.w. x 6 doses (dose-escalation) \* The dosage regimen would be escalated gradually until MTD had been found out.
- interventionNames
- Drug: Lipotecan® (TLC388)
Primary outcomes (4)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- week 12
- description
- Maximum tolerated dose
- measure
- PVTT response rate
- timeFrame
- week7
- description
- PVTT response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Females or males 20-70 years of age (inclusive) * Patients with histological confirmed HCC or other conditions * Patients with locally advanced HCC and PVTT that is not suitable for other local therapies * Other inclusion criteria also apply Exclusion Criteria: * Females who are pregnant/lactating or planning to be pregnant, or patients of childbearing potential who are not using medically recognized method of contraception. * Patients with documented extrahepatic metastasis * Patients with stage III-IV encephalopathy or tense ascites * Patients who have received any local or systemic therapy for HCC within 4 weeks prior to the initiation of study treatment * Patients who have received Lipotecan® treatment prior to the initiation of study treatment * Other exclusion criteria also apply
References
Publications (0)
Data not yet available