Clinical trial · Interventional
Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma
NCT00784290CI-TRIAL-00006588completedPhase 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
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived growth factor receptor, and fibroblast growth factor receptor, in patients with advanced hepatocellular carcinoma (HCC).
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 |
|---|---|---|---|
| Orantinib (TSU-68) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Orantinib
- interventionNames
- Drug: Orantinib (TSU-68)
Primary outcomes (2)
- measure
- Step 1(Phase I) Safety
- timeFrame
- During chemotherapy
- measure
- Step 2(Phase II) Response rate(RR)
- timeFrame
- Until progression
Secondary outcomes (2)
- measure
- Step 1(Phase I) Response rate(RR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Age 20-74 * PS 0-2 * Patients who did not respond to surgery, RFA, TAE, chemotherapy, or radiotherapy * Chid-Pugh A or B * At least one measurable lesion by RECIST criteria Exclusion Criteria: * Large amount of pleural effusion or ascites * Esophageal varices * Simultaneously active double cancer
References
Publications (2)
- DERIVEDEnooku K, Tateishi R, Kanai F, Kondo Y, Masuzaki R, Goto T, Shiina S, Yoshida H, Omata M, Koike K. Evaluation of molecular targeted cancer drug by changes in tumor marker doubling times. J Gastroenterol. 2012 Jan;47(1):71-8. doi: 10.1007/s00535-011-0462-2. Epub 2011 Sep 21. PMID 21935635
- DERIVEDKanai F, Yoshida H, Tateishi R, Sato S, Kawabe T, Obi S, Kondo Y, Taniguchi M, Tagawa K, Ikeda M, Morizane C, Okusaka T, Arioka H, Shiina S, Omata M. A phase I/II trial of the oral antiangiogenic agent TSU-68 in patients with advanced hepatocellular carcinoma. Cancer Chemother Pharmacol. 2011 Feb;67(2):315-24. doi: 10.1007/s00280-010-1320-2. PMID 20390419