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Hepatocellular CarcinomaPhase 2STARTNCT00990860

Study in Asia of the Combination of TACE With Sorafenib in HCC Patients

A Phase 2 study testing doxorubicin and TACE (Transcatheter arterial chemoembolization) in people with Hepatocellular Carcinoma, run by Taipei Veterans General Hospital, Taiwan at 8 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

TACE possibly plays a significant role in contributing to a subgroup of surviving residual tumor tissue which is characterized by more aggressive biology. This explains the strong scientific rationale for exploring the role of anti-angiogenic therapy such as sorafenib to remedy and strengthen the therapeutic efficacy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
doxorubicin and TACE (Transcatheter arterial chemoembolization)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
8 sitesTaiwan
Study dates
Feb 2009to Feb 2011
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≧ 18
  • life expectancy > 12 weeks
  • Histologically diagnosed HCC, OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis. A clinically diagnosed HCC should fulfill ALL the criteria below
  • Chronic hepatitis B or C and/or evidence of liver cirrhosis.
  • Presence of hepatic tumour(s) with image findings compatible with HCC, and no evidence of other gastrointestinal tumours
  • A persistent elevation of serum AFP >= 400 ng/ml without any evidence of an existing α-fetoprotein-secreting germ cell tumour
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  • Child-Pugh score ≦ 7
  • BCLC B
  • The patient must have a solitary hepatic tumour greater than 3 cm in diameter or multifocal disease as evidenced by CT or MRI scanning.
  • The target lesion must not have been previously treated with local therapy
  • The patient must not be a candidate for surgical resection or ablation of the tumour. Size of largest tumor ≦10cm in largest dimension
  • Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible
  • Local therapy must have been completed at least 4 weeks prior to baseline scan.
  • ECOG performance status 0 or 1
  • Hb ≧ 9g/dL,
  • Absolute neutrophil count > 1000/mm3
  • Platelet count ≧ 60x109/L
  • Adequate clotting function: INR < 1.5
  • Hepatic: AST or ALT < 5 X ULN
  • Renal: serum creatinine < 1.5 x ULN
  • Bilirubin ≦ 3mg/dL
  • The patient must give written, informed consent

Who cannot join

  • Tumor factors
  • Presence of extrahepatic metastasis
  • Predominantly infiltrative lesion
  • Diffuse tumor morphology with extensive lesions involving both lobes.
  • Vascular complications
  • Hepatic artery thrombosis, or
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  • Partial or complete thrombosis of the main portal vein, or
  • Tumor invasion of portal branch of contralateral lobe, or
  • Hepatic vein tumor thrombus, or
  • Significant arterioportal shunt not amenable to shunt blockage
  • Liver function
  • Advanced liver disease: ascites, hepatic encephalopathy
  • Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry.
  • Others
  • Pregnant or lactating women.
  • Active sepsis or bleeding.
  • Hypersensitivity to intravenous contrast agents.
  • The patient has received prior treatment for HCC target lesion.
  • History of cardiac disease
  • Congestive heart failure > NYHA class 2; active coronary artery disease
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
  • Hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management.
  • Therapeutic anticoagulation with coumarin, heparins, or heparinoids.
  • Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months.
  • Impairment of swallowing that would preclude administration of sorafenib.
  • The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions.
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated > 3 years prior to entry is permitted
  • Any active clinically serious infections (> grade 2 NCI-CTCAE ver 3.0)
  • HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Taiwan8 sites

  • E-Da hospital

    Kaohsiung City

  • Veterans General Hospital- Kaochiung

    Kaoshiung

  • Veterans General Hospital- Taichung

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Mackay Memorial Hospital

    Taipei

  • Tri- Service General Hospital

    Taipei

  • Veterans General Hospital- Taipei

    Taipei

  • Chang-Gung Memorial Hospital- LinKou

    TaoYuan Hsien

Other trials in Taiwan

About this study

Official title: START (Study in Asia of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib in Hepatocellular Carcinoma (HCC) Patients) Trial

TACE possibly plays a significant role in contributing to a subgroup of surviving residual tumor tissue which is characterized by more aggressive biology. This explains the strong scientific rationale for exploring the role of anti-angiogenic therapy such as sorafenib to remedy and strengthen the therapeutic efficacy of TACE to combat liver cancers. Sorafenib plays a prominent auxiliary role by further suppressing the tumor growth and prolonging the time to recurrence and progression. Performing TACE under sorafenib administration may have synergic effect on hepatic tumoral lesions.

Being tested
doxorubicin, TACE (Transcatheter arterial chemoembolization)
Keywords
Combination of TACE With Sorafenib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • doxorubicinDrug

    After identifying the target artery of HCC, doxorubicin will be infused through the target artery of HCC patient with lipiodol emulsion (dependent on the tumor size)

  • TACE (Transcatheter arterial chemoembolization)Procedure or surgery

    TACE (Transcatheter arterial chemoembolization)

Study groups in NCT00990860
Study groupRoleWhat they receive
SorafenibExperimentalNot described
Receives: Drug: doxorubicin; Procedure: TACE (Transcatheter arterial chemoembolization)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability (such as adverse events and laboratory changes (haematology, clinical chemistry))

    Measured: 2 years

Secondary outcomes (4)

  1. Time to Progression

    Measured: 2 years

  2. Overall survival

    Measured: 2 years

  3. Progression Free Survival

    Measured: 2 years

  4. No. of TACE cycles

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionFeb 2011 (estimated)

Resources

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00990860
Sponsor's protocol ID
ISS-13967
Other IDs
ISS-13967
Acronym
START
Status last verified
Jun 2010
First submitted
1 Sep 2009
Last updated
5 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • Chao Y, Chung YH, Han G, Yoon JH, Yang J, Wang J, Shao GL, Kim BI, Lee TY. The combination of transcatheter arterial chemoembolization and sorafenib is well tolerated and effective in Asian patients with hepatocellular carcinoma: final results of the START trial. Int J Cancer. 2015 Mar 15;136(6):1458-67. doi: 10.1002/ijc.29126. Epub 2014 Sep 16.

    PubMed 25099027

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing doxorubicin and TACE (Transcatheter arterial chemoembolization) in people with Hepatocellular Carcinoma, run by Taipei Veterans General Hospital, Taiwan at 8 sites in Taiwan.

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 22 inclusion and 29 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 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Taiwan. 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?

Safety and tolerability (such as adverse events and laboratory changes (haematology, clinical chemistry)) (time frame: 2 years). 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 NCT00990860, which also lists 1 linked publication.

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 5 Jan 2011.

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