Clinical trial · Interventional
Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
A Phase I/II, Dose-escalation Study of Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
NCT03035006CI-TRIAL-00035648terminatedPhase 1 / Phase 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)
This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis.
Conditions
Conditions (2)
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 |
| Portal Vein Tumor Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lipotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lipotecan based chemoradiotherapy
- description
- Patients will receive Lipotecan based CCRT. Lipotecan will be given as a 30-minute (±3 minutes) iv infusion qw for 6 weeks at the predefined dose level for each cohort. A total of 6 doses of Lipotecan will be administered to each patient in conjunction with RT at 3.5 Gy per fraction for 16 fractions. During CCRT period, Lipotecan should be given within 2 hours prior to the start of RT, and the Lipotecan and RT should be delivered on the same day, unless any conditions fulfils with the dose interruption standards. Radiotherapy treatment, at the allocated dose level, is only permitted if the normal tissue dose constrain criteria are maintained
- interventionNames
- Drug: Lipotecan
Primary outcomes (2)
- measure
- Maximum tolerated dose determination for Lipotecan based CCRT
- timeFrame
- 3 months
- description
- To determine maximum tolerated dose for Lipotecan based CCRT in HCC patients with portal vein tumor thrombosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients will be males or females * ≥20 years of age in Taiwan * ≥18 years old in China 2. Patients with histologically confirmed HCC or patients who do not have histological diagnosis, but the lesion is larger than 1 cm in a cirrhotic liver with typical HCC image of contrast enhanced CT scan or MRI. If the image characteristic is not typical of HCC, another contrast enhanced image modality should be confirmed for diagnosis. 3. Patients with PVTT (BCLC stage C) who are not suitable for local therapies 4. Patients with a measureable targeting lesion 5. Patients with an anticipated residual life expectancy ≥3 months 6. Patients who have adequate organ function 7. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2 8. Patients who are willing to follow birth control requirements during the study treatment and continue until 2 months after the completion of study treatment 9. Patients willing and able to comply with the study procedures and to sign a written ICF Exclusion Criteria: 1. Patients with infiltrative type HCC 2. Patients with evidence of any extrahepatic metastasis, including but not limited to inferior vena cava thrombosis, bone metastasis, brain metastasis, or regional lymph node metastasis 3. Patients with a history of West Haven criteria grade III-IV hepatic encephalopathy or ascites 4. Patients with a history of other malignancy except primary HCC within 3 years prior to the screening visit, excluding skin squamous cell carcinoma or basal cell carcinoma 5. Patients who fail to follow the radiation dose constraint in any critical organ in the radiotherapy planning 6. Patients with an inadequately defined hepatic tumor margin for RT planning on MRI or CT that may impact treatment or safety based on investigator's judgment 7. Patients who have experienced significant allergy or hypersensitivity to the contrast medium for CT or MRI that makes it unsafe to perform the delineation for RT planning 8. Patients with a history of liver transplantation 9. Patients with a significant concurrent disease
References
Publications (0)
Data not yet available
No reference posted for this study.