Hepatocellular CarcinomaPhase 2TACTICSNCT01217034
Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib
A Phase 2 study testing TACE with sorafenib and TACE alone in people with Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by Kindai University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the combination therapy with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical resection or percutaneous ablation… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Carcinoma, Hepatocellular
- What is being tested?
- TACE with sorafenib and TACE alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2010to Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 17Show fewer
- 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.
- 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
Who cannot join
- 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
- 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
Show all 35Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study: Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)
The purpose of this study is to evaluate the safety and efficacy of the combination therapy with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical resection or percutaneous ablation therapy.
Read the detailed description
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
- Conditions
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm
- Being tested
- TACE with sorafenib, TACE alone
- Keywords
- Transcatheter arterial chemoembolization, TACE, sorafenib, Time to untreatable progression, TTUP
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE with sorafenibDrug
Also called TACE with Nexavar
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.
TACE aloneProcedure or surgery
Also called TACE
TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| TACE with sorafenib | Experimental | TACE(on demand) with sorafenib till untreatable progression Receives: Drug: TACE with sorafenib |
| TACE alone | Active comparator | TACE(on demand) till unreatable progression Receives: Procedure: TACE alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Patients will be evaluated for these endpoints every 8 weeks
Measured: every 8 week
Overall Survival
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.
Measured: every 8 week
Secondary outcomes (9)
Time To Progression
Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week.
Measured: every 8 weeks
Objective Response Rate
Objective Response Rate is defined as best response
Measured: 4week after TACE
Tumor markers
Change of tumor markers
Measured: every 4 weeks
Safety
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)
Measured: every 4 weeks
Time To Untreatable Progression(TTUP)
Time to untreatable progression is defined as time from randomization to untreatable progression and will be evaluated every 8 week.
Measured: every 8 week till untreatable progression, assessed up to 100 months
Time to Child-Pugh C
Time to Child-Pugh C is defined as time from randomization to Child-Pugh C and will be evaluated every 8 week.
Measured: every 8 week till liver deterioration to Child-Pugh C, assessed up to 100 months
Time to intrahepatic tumor progression
Time to intrahepatic tumor progression is defined as time from randomization to intrahepatic tumor progression and will be evaluated every 8 week.
Measured: every 8 week till intrahepatic tumor progression, assessed up to 100 months
Time to vascular invasion
Time to vascular invasion is defined as time from randomization to vascular invasion and will be evaluated every 8 week.
Measured: every 8 week till vascular invasion, assessed up to 100 months
Time to Extrahepatic spread
Time to extrahepatic spread is defined as time from randomization to extrahepatic spread and will be evaluated every 8 week.
Measured: every 8 week till extrahepatic spread, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kindai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masatoshi Kudo, Kindai University
- Investigators
- Masatoshi Kudo, Professor, Principal investigator, Kindai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217034
- Sponsor's protocol ID
- JLOG 1001 trial
- Acronym
- TACTICS
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2010
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Moriguchi M, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Ogasawara S, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y. Final Results of TACTICS: A Randomized, Prospective Trial Comparing Transarterial Chemoembolization Plus Sorafenib to Transarterial Chemoembolization Alone in Patients with Unresectable Hepatocellular Carcinoma. Liver Cancer. 2022 Feb 10;11(4):354-367. doi: 10.1159/000522547. eCollection 2022 Jul.
PubMed 35978604Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Yasui K, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Yokosuka O, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y; TACTICS study group. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2020 Aug;69(8):1492-1501. doi: 10.1136/gutjnl-2019-318934. Epub 2019 Dec 4.
PubMed 31801872
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)
- ClinicalTrials.gov ID
- NCT01217034
- Acronym / sponsor ID
- TACTICS / JLOG 1001 trial
- Conditions
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm
- Keywords
- Transcatheter arterial chemoembolization, TACE, sorafenib, Time to untreatable progression, TTUP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Kindai UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of the combination therapy with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical resection or percutaneous ablation therapy.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE with sorafenib | Experimental | Drug: TACE with sorafenibTACE(on demand) with sorafenib till untreatable progression |
| TACE alone | Active comparator | Procedure: TACE aloneTACE(on demand) till unreatable progression |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (35 listed)
- History of malignant tumor, excluding the following cases:
- Cardiac disease that meet any of the following criteria:
- Serious and active infection, except for HBV and HCV
- History of HIV infection
- Renal dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE with sorafenibAlso: TACE with NexavarSorafenib 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. | Drug | TACE with sorafenib |
| TACE aloneAlso: TACETACE will be conducted at scheduled day. When tumor increases, TACE will be repeated. | Procedure or surgery | TACE alone |
Primary outcome
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.
9 secondary outcomes
Time To Progression
Time frame: every 8 weeks
Objective Response Rate
Time frame: 4week after TACE
Tumor markers
Time frame: every 4 weeks
Safety
Time frame: every 4 weeks
Time To Untreatable Progression(TTUP)
Time frame: every 8 week till untreatable progression, assessed up to 100 months
Time to Child-Pugh C
Time frame: every 8 week till liver deterioration to Child-Pugh C, assessed up to 100 months
Time to intrahepatic tumor progression
Time frame: every 8 week till intrahepatic tumor progression, assessed up to 100 months
Time to vascular invasion
Time frame: every 8 week till vascular invasion, assessed up to 100 months
Time to Extrahepatic spread
Time frame: every 8 week till extrahepatic spread, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 35978604Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Moriguchi M, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Ogasawara S, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y. Final Results of TACTICS: A Randomized, Prospective Trial Comparing Transarterial Chemoembolization Plus Sorafenib to Transarterial Chemoembolization Alone in Patients with Unresectable Hepatocellular Carcinoma. Liver Cancer. 2022 Feb 10;11(4):354-367. doi: 10.1159/000522547. eCollection 2022 Jul.
- Derived from this study: PubMed 31801872Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Yasui K, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Yokosuka O, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y; TACTICS study group. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2020 Aug;69(8):1492-1501. doi: 10.1136/gutjnl-2019-318934. Epub 2019 Dec 4.
Related trials for Hepatocellular Carcinoma
Not yet recruitingPhase 2
NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruiting
Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response
Hepatocellular Carcinoma, Liver Cancer
Active, not recruitingObservational study
Detect and Expunge Concealed Tumors of the Liver
Liver Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masatoshi Kudo, Professor principal investigator
Kindai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TACE with sorafenib and TACE alone in people with Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by Kindai University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: every 8 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217034, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.