Phase II study: Transcatheter Arterial Chemoembolization Therapy In Combination with Sorafenib (TACTICS) - TACTICS

Japan Liver Oncology Group0 sites228 target enrollmentOctober 4, 2010

ConditionsHCC

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: HCC
Sponsor: Japan Liver Oncology Group
Enrollment: 228
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 4, 2010

End Date

July 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Japan Liver Oncology Group

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\) History of malignant tumor 2\) Severe cardiac disease 3\) Serious and active infection, except for HBV and HCV 4\) History of HIV infection 5\) Renal dialysis 6\) Diffuse tumor lesion 7\) Extrahepatic metastasis 8\) Vascular invasion 9\) Intracranial tumor 10\) Preexisting or history of hepatic encephalopathy 11\) Clinically uncontrolled ascites or pleural effusion 12\) Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment 13\) Esophageal and/or gastric varices which has high risk of bleeding 14\) History of thrombosis and/or embolism within 6 months of the start of treatment 15\) History of receiving any of the following therapies: a) Systemic chemotherapy for advanced HCC b) Local therapy, such as radiofrequency ablation, TACE, or hepatic arterial infusion within 3 months of the start of treatment c) Current treatment with CYP3A4 inducing agents d) Invasive surgery within 4 weeks of the start of treatment e) History of allogenic transplantation f) History of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study 16\) Unable to take oral medications 17\) Gastrointestinal problems that may affect absorption or pharmacokinetics of the study drugs 18\) Use of drugs that may affect absorption or pharmacokinetics of the study drugs 19\) Concurrent disease or disability that may affect evaluation of the effects of the study drugs 20\) Enrollment in another study within 4 weeks of study entry 21\) Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant 22\) Risk of allergic reactions to the study drugs 23\) Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results 24\) Any condition that could jeopardize the safety of the patient or their compliance in the study