Clinical trial · Interventional
Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
NCT01807156CI-TRIAL-00021896terminatedPhase 2Results postedClinicalTrials.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): Primary endpoint not met
Summary
Brief summary (as posted)
The purpose of this study is to learn about the effect of the investigational agent tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also plan to collect information on the likelihood to develop side effects while on this treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is designed to stop the tumor from developing new blood vessels.
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 Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tivozanib | Drug | Tivozanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tivozanib
- description
- Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
- interventionNames
- Drug: Tivozanib
Primary outcomes (1)
- measure
- Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression
- timeFrame
- 6 Months
- description
- Evaluation of disease progression in the patients with advanced hepatocellular cancer (HCC) receiving tivozanib will be made using CT or MRI scan of the organ(s) with the target lesion(s). Response Evaluation Criteria In Solid Tumors (RECIST) criteria 1.1 will be used for objective tumor response assessment. Measurable lesions can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan. Target lesions are all measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients with measurable, histological diagnosis of hepatocellular carcinoma (HCC) and whose disease is not amenable to surgical or regional therapy.
2. Prior allowed therapy:
* Surgery including hepatic resection
1. Minimum of 4 weeks since any surgical procedure.
2. Patients must have adequately recovered from surgery.
* Regional therapy
1. Includes transarterial chemoembolization (TACE), drug-eluting bead \[DEB\]-TACE, percutaneous ethanol injection, radiofrequency/cryo ablation, Yttrium-90 radioembolization.
2. More than 2 weeks must have lapsed from therapy.
3. There must be an indicator lesion outside the treated area or clear evidence of progression in the treated lesion, not amenable for further local therapies.
4. Concomitant sorafenib with regional therapy is allowed as long as no evidence of progression on sorafenib.
* Prior adjuvant sorafenib is allowed, if completed more than 6 months prior to disease recurrence.
3. Adequate hematological, liver and metabolic organ function.
4. Signed informed consent.
Exclusion Criteria:
1. Patients with mixed histology or fibrolamellar variant.
2. Prior systemic therapy for metastatic disease.
3. Uncontrolled hypertension (HTN).
4. Symptomatic heart failure.References
Publications (0)
Data not yet available
No reference posted for this study.