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Hepatocellular CarcinomaPhase 4NCT02504983

Clinical Trial for GALNT14 Genotype - Guided, Sorafenib in Combination With TACE in Hepatocellular Carcinoma

A Phase 4 study testing sorafenib and TACE in people with Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Transcatheter arterial chemoembolization (TACE) + sorafenib therapy has been demonstrated to exert a beneficial effective on time-to-tumor-progression (TTP) in patients with unresectable hepatocellular carcinoma (HCC) in some studies. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
sorafenib and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTaiwan
Study dates
Aug 2015to Jul 2021
Phase
Phase 4
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed Diagnosis of HCC:
  • Cirrhotic subjects: Clinical diagnosis by AASLD criteria HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2cm with contrast uptake in the arterial phase and washout in venous or late phases, or two imaging techniques showing this radiological behaviour for nodules of 1-2cm in diameter Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria
  • Non-cirrhotic subjects:
  • For subjects without cirrhosis, histological confirmation is mandatory Documentation of original biopsy for diagnosis is acceptable
  • Never received TACE/ chemotherapy/ radiotherapy or targeted agents prior to this study.
  • Patients should be either in BCLC clinical stage B (multinodular asymptomatic tumors without extra-hepatic spread or portal vein invasion) with or without unilateral secondary or tertiary branches of portal vein invasion. Main portal vein invasion or extra-hepatic spread is not allowed.
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  • Child-Pugh functional class A or B.
  • Measurable disease using mRECIST criteria. At least 1 measurable lesion must be present.
  • ECOG performance status 0 to 1.
  • Age > 18 years
  • Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial and 4 weeks after the completion of trial
  • Informed consent must be obtained prior to study initiation.
  • Total bilirubin < 3.0 mg/dL with no evidence of biliary tract obstruction.
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 × upper limit of normal.
  • Absolute neutrophil count > 1000/mm3; Platelets ≧ 60x109/L.
  • Serum creatinine < 2 x ULN.
  • Antiviral treatment for hepatitis B or C is allowed except for interferon.

Who cannot join

  • BCLC stage A.
  • Presence of extrahepatic metastasis.
  • Child-Pugh score =C
  • Significant cardiac disease.
  • Serious bacteria infection requiring systemic antibiotics.
  • Pregnancy
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  • Expected non-compliance.
  • Uncontrolled illness including, but not limited to, ongoing infection, congestive hear failure, unstable angina pectoris, cardiac arryhythmia, or psychiatric illness.
  • Bleeding esophageal or gastric varices within three months without ligation or sclerosis injection therapy.
  • Subjects with known HIV infection.
  • ECOG status > or = 2

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

About this study

Official title: Randomized, Open Label, Clinical Trial for GALNT14 Genotype - Guided, Sorafenib in Combination With TACE Therapy in Hepatocellular Carcinoma

Transcatheter arterial chemoembolization (TACE) + sorafenib therapy has been demonstrated to exert a beneficial effective on time-to-tumor-progression (TTP) in patients with unresectable hepatocellular carcinoma (HCC) in some studies. However, the beneficial effect varies among studies conducted in different areas of the world. The objectives of this study are (1) to understand whether GALNT14 TT genotype patients respond better than do GALNT14 non-TT genotype patients when treated by TACE; and (2) to understand whether GALNT14 non-TT genotype patients can benefit from TACE plus sorafenib (Nexavar) combination therapy. Patients enrolled will be stratified by GALNT14 genotyping. The GALNT14 "non-TT" patients were then randomized into two subgroups to evaluate the safety, tolerability and efficacy of TACE plus sorafenib therapy.

The primary endpoint of this study is the efficacy of TACE with or without sorafenib combination therapy evaluated by complete remission (CR).

Read more

The secondary endpoints are:

  1. Time to partial or complete response (PR + CR).
  2. Time-to-tumor-progression (TTP) and the progression free survival (PFS).
  3. Overall survival (OS).
  4. Safety and tolerability of TACE plus sorafenib therapy.
Read the detailed description

The strategy of TACE + sorafenib is now being intensively investigated. It is a safe approach with significant beneficial effect on TTP in some studies, but the beneficial effect on OS remains uncertain. In the present study, we hypothesized that the GALNT14 genotype might play a role in this issue. Our pilot study indicated that GALNT14 "TT" genotype was associated with a favorable complete response rate in patients treated by TACE alone. This genotype was present in ~ 25% of Chinese population coming from Taiwan, Colorado (US), or Beijing (China), and in ~ 7% of Italian population. But it was present in ~ 50% of Japanese population. The lower percentage of a TACE - favorable genotype in Chinese and Italian population could explain the different results between Japanese and Chinese/Italian clinical trials. It is possible that in a population with higher percentage of TACE - favorable genotype (GALNT14 "TT"), the beneficial effect of sorafenib adjuvant treatment might not be detected. In this study, we proposed to examine the TACE + sorafenib effect in patients with GALNT14 "non-TT" genotype, a TACE - unfavorable genotype.

Being tested
sorafenib, TACE
Keywords
SNPs
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • sorafenibDrug

    Also called Nexavar

    sorafenib is an oral, multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma

  • TACEProcedure or surgery

    Also called Transcatheter arterial chemoembolization

    Transcatheter arterial chemoembolization was performed by the injection of small embolic particles coated with chemotherapeutic agents selectively into an artery directly supplying a tumor.

Study groups in NCT02504983
Study groupRoleWhat they receive
GALNT14 TTActive comparatorPatients will be treated by Transcatheter arterial chemoembolization every 12 ± 2 weeks dependent on CT evaluation. Before each TACE, dynamic CT will be performed for pre-treatment evaluation. When no viable tumor is seen on CT, TACE is to be discontinued.
Receives: Procedure: TACE
GALNT14 non-TT TACE aloneActive comparatorPatients will be treated by Transcatheter arterial chemoembolization every 12 ± 2 weeks dependent on CT evaluation. Before each TACE, dynamic CT will be performed for pre-treatment evaluation. When no viable tumor is seen on CT, TACE is to be discontinued.
Receives: Procedure: TACE
GALNT14 non-TT TACE plus sorafenibExperimentalPatients will be treated by Transcatheter arterial chemoembolization every 12 ± 2 weeks dependent on CT evaluation, plus sorafenib adjuvant therapy. Before each TACE, dynamic CT will be performed for pre-treatment evaluation. When no viable tumor is seen on CT, TACE is to be discontinued. patients will receive sorafenib 400 mg/d between each TACE. Patient will start receiving Sorafenib on Day 4 (up to Day 7) after 1st TACE (Day 1) and will interrupt after evening dose 4 days before each next TACE and re-start Sorafenib on Day 4 (up to Day 7) after each TACE cycle.Additional sorafenib treatment is optional and will be judged by investigator in the subject's best medical interest.
Receives: Drug: sorafenib; Procedure: TACE

What is being measured

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

  1. Complete remission

    Measured: 3 years

Secondary outcomes (5)

  1. Time to partial (including complete) response

    Measured: 3 years

  2. Time-to-tumor-progression (TTP)

    Measured: 3 years

  3. Progression free survival (PFS).

    Measured: 3 years

  4. Overall survival (OS)

    Measured: 3 years

  5. Safety and tolerability of TACE plus sorafenib therapy recorded and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.

    Measured: 3 years

Timeline

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

  1. First posted22 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJul 2021 (estimated)
  4. Study completionJul 2021 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02504983
Sponsor's protocol ID
104-1686A3
Status last verified
Feb 2020
First submitted
16 Jul 2015
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Liang KH, Lin CL, Chen SF, Chiu CW, Yang PC, Chang ML, Lin CC, Sung KF, Yeh C, Hung CF, Chien RN, Yeh CT. GALNT14 genotype effectively predicts the therapeutic response in unresectable hepatocellular carcinoma treated with transcatheter arterial chemoembolization. Pharmacogenomics. 2016 Mar;17(4):353-66. doi: 10.2217/pgs.15.179. Epub 2016 Feb 12.

    PubMed 26871639

  • Chen WT, Lin SM, Lee WC, Wu TJ, Lin CC, Shen CH, Chang ML, Lin CL, Yeh CT. GALNT14 genotype-guided chemoembolization plus sorafenib therapy in hepatocellular carcinoma: a randomized trial. Hepatol Int. 2022 Feb;16(1):148-158. doi: 10.1007/s12072-021-10283-7. Epub 2022 Jan 4.

    PubMed 34982369

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sorafenib and TACE in people with Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site 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 17 inclusion and 11 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 Feb 2020. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Complete remission (time frame: 3 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 NCT02504983, 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 5 Feb 2020.

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