Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)
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ClinicalTrials.gov Identifier: NCT01217034 |
Recruitment Status : Unknown
Verified October 2017 by Masatoshi Kudo, Kindai University.
Recruitment status was: Active, not recruiting
First Posted : October 8, 2010
Last Update Posted : October 31, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma Unresectable Hepatocellular Carcinoma Carcinoma, Hepatocellular Liver Neoplasm | Drug: TACE with sorafenib Procedure: TACE alone | Phase 2 |
TACE with sorafenib Group
Sorafenib will be administrated at a dose of 400mg o.d. before the first TACE. After 2days drug rest, TACE will be conducted. Sorafenib will be resumed at a dose of 400mg o.d. from 3 days after TACE(the resumption day can be postponed until 21 days after TACE). When tolerability is confirmed at 1 week after resumption, the dose of sorafenib will be increased to 400mg b.i.d. When tumor increases, TACE will be repeated.
Control group
TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.
The treatment regimen will be continued until untreatable progression which is defined as follows:
- Child-Pugh grade C
- Tumor growth (125 percent from baseline status)
- Vascular invasion(Vp3,Vp4)
- Extra hepatic spread which size is more than 10mm
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 228 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study: Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS) |
Study Start Date : | October 2010 |
Estimated Primary Completion Date : | March 2018 |
Estimated Study Completion Date : | March 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: TACE with sorafenib
TACE(on demand) with sorafenib till untreatable progression
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Drug: TACE with sorafenib
Sorafenib will be administrated at a dose of 400mg o.d. before the first TACE. After 2days drug rest, TACE will be conducted. Sorafenib will be resumed at a dose of 400mg o.d. from 3 days after TACE(the resumption day can be postponed until 21 days after TACE). When tolerability is confirmed at 1 week after resumption, the dose of sorafenib will be increased to 400mg b.i.d. When tumor increases, TACE will be repeated.
Other Name: TACE with Nexavar |
Active Comparator: TACE alone
TACE(on demand) till unreatable progression
|
Procedure: TACE alone
TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.
Other Name: TACE |
- Progression Free Survival [ Time Frame: every 8 week ]Patients will be evaluated for these endpoints every 8 weeks
- Overall Survival [ Time Frame: every 8 week ]The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively.
- Time To Progression [ Time Frame: every 8 weeks ]Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week.
- Objective Response Rate [ Time Frame: 4week after TACE ]Objective Response Rate is defined as best response
- Tumor markers [ Time Frame: every 4 weeks ]Change of tumor markers
- Safety [ Time Frame: every 4 weeks ]Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)
- Time To Untreatable Progression(TTUP) [ Time Frame: every 8 week till untreatable progression, assessed up to 100 months ]Time to untreatable progression is defined as time from randomization to untreatable progression and will be evaluated every 8 week.
- Time to Child-Pugh C [ Time Frame: every 8 week till liver deterioration to Child-Pugh C, assessed up to 100 months ]Time to Child-Pugh C is defined as time from randomization to Child-Pugh C and will be evaluated every 8 week.
- Time to intrahepatic tumor progression [ Time Frame: every 8 week till intrahepatic tumor progression, assessed up to 100 months ]Time to intrahepatic tumor progression is defined as time from randomization to intrahepatic tumor progression and will be evaluated every 8 week.
- Time to vascular invasion [ Time Frame: every 8 week till vascular invasion, assessed up to 100 months ]Time to vascular invasion is defined as time from randomization to vascular invasion and will be evaluated every 8 week.
- Time to Extrahepatic spread [ Time Frame: every 8 week till extrahepatic spread, assessed up to 100 months ]Time to extrahepatic spread is defined as time from randomization to extrahepatic spread and will be evaluated every 8 week.
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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged 20 Years or over
- Patients who were fully informed of the study beforehand and signed the informed consent to participate in the study.
- Patients who are expected to live more than 12 weeks.
- Patients diagnosed with typical HCC by biopsy,cytology, or diagnostic imaging such as dynamic CT(MRI).Typical HCC is defined by AASLD criteria.
- Patients in whom complete resection of the tumor by hepatectomy or complete tumor necrosis by local tumor necrosis therapy(RFA) cannot be expected to succeed.
- Patients with tumors which are confirmed to the liver and can be treated by TACE(the maximum diameter equal to or less than 10cm,and the maximum number of nodule equal to or less than 10).
- Patients with viable and measurable target lesion.
- patients with no or one history of TACE therapy.
- patients with an ECOG PS(Performance Status) Score of 0 or 1.
- patients with Child-Pugh class A.
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Patients with laboratory values that meet the following criteria:
- Hemoglobin ≥ 8.5 g/dl
- Granulocytes ≥ 1500/mm3
- Platelet count ≥ 50,000 /mm3
- Total serum bilirubin ≤ 3 mg/dl
- AST and ALT ≤ 6 times upper limits of normal
- Serum creatinine ≤ 1.5 times upper limits of normal
Exclusion Criteria:
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History of malignant tumor, excluding the following cases:
- Curatively treated early stage cancer with a low risk of recurrence ,such as carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumor, and early gastric cancer.
- Malignant tumor that was curatively treated more than 3 years prior to study entry and has not recurred since then
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Cardiac disease that meet any of the following criteria:
- NYHA Class III or higher congestive heart failure
- History of symptomatic coronary artery disease or myocardial infarction within 6 months before enrollment
- Arrhythmia requiring control by antiarrhythmic drugs such as beta-blockers or digoxin
- Serious and active infection, except for HBV and HCV
- History of HIV infection
- Renal dialysis
- Diffuse tumor lesion
- Extrahepatic metastasis
- Vascular invasion
- Intracranial tumor
- Preexisting or history of hepatic encephalopathy
- Clinically uncontrolled ascites or pleural effusion
- Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
- Esophageal and/or gastric varices which has high risk of bleeding
- History of thrombosis and/or embolism within 6 months of the start of treatment
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History of receiving any of the following therapies:
- Systemic chemotherapy for advanced HCC(including sorafenib therapy)
- Local therapy, such as radiofrequency ablation, TACE, or hepatic arterial infusion within 3 months of the start of treatment
- Current treatment with CYP3A4 inducing agents
- Invasive surgery within 4 weeks of the start of treatment
- History of allogenic transplantation
- History of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study
- Unable to take oral medications
- Gastrointestinal problems that may affect absorption or pharmacokinetics of the study drugs
- Use of drugs that may affect absorption or pharmacokinetics of the study drugs
- Concurrent disease or disability that may affect evaluation of the effects of the study drugs
- Enrollment in another study within 4 weeks of study entry
- Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant
- Risk of allergic reactions to the study drugs
- Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
- Any condition that could jeopardize the safety of the patient or their compliance in the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217034
Japan | |
Kinki University Hospital | |
Osaka-Sayama, Osaka, Japan, 589-8511 |
Principal Investigator: | Masatoshi Kudo, Professor | Kindai University |
Responsible Party: | Masatoshi Kudo, Professor, Kindai University Faculty of Medicine, Department of Gastroenterology and Hepatology, Kindai University |
ClinicalTrials.gov Identifier: | NCT01217034 |
Other Study ID Numbers: |
JLOG 1001 trial |
First Posted: | October 8, 2010 Key Record Dates |
Last Update Posted: | October 31, 2017 |
Last Verified: | October 2017 |
Transcatheter arterial chemoembolization TACE sorafenib Time to untreatable progression TTUP |
Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Sorafenib |
Chlorotrianisene Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |