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Carcinoma, HepatocellularPhase 3NCT02788526

Adjuvant TACE to Reduce the HCC Recurrence After Resection

A Phase 3 study testing Adjuvant TACE and Follow-up in people with Carcinoma, Hepatocellular, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Adjuvant TACE and Follow-up
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
Jun 2009to Jun 2015
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18~75 years;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score <=2;
  • Histologically confirmed hepatocellular carcinoma with microvessels invasion;
  • No previous treatment for HCC;
  • More than 5 cm solitary tumor before surgery confirmed by more than 2 radiological examinations;
  • R0 resection achieved;
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  • No recurrence evidence in radiological follow-up 3~7 weeks after surgery;
  • Adequate hematologic parameters and liver and kidney functions: (1) Neutrophils Absolute >=1.5*10^9/L; (2) Hemoglobin >=90g/L; (3) Platelet count >=75*10^9/L; (4) Serum albumin >=35g/L; (5) Serum total bilirubin <=1.5* upper limit of normal (ULN); (6) Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <2.5*ULN; (7) Serum creatinine <=1.5*ULN; (8) International normalized ratio (INR) <=1.5;
  • Give signed informed consent before enrollment.

Who cannot join

  • Function impairment of vital organs (heart, lung, kidney, etc), serious infection or >grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0);
  • Histologically confirmed of positive resection margin (R1 resection);
  • Previous or current malignant tumor beyond HCC;
  • Allergy to any agent of the TACE regimen;
  • History of organ transplantation;
  • Previously receiving other treatments for HCC;
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  • Pregnant or breastfeeding women, and women of childbearing potential without adequate contraception;
  • Neurological or mental abnormalities that may affect cognitive assessment and inform consent;
  • Concomitant anti-tumor therapy or participating in other interventional clinical trials;
  • Other psychological, family or social reason, which would affect compliance with the study protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

  • SUN YAT-SEN University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: The Clinical Randomized Trial of Adjuvant Transarterial Chemo Embolization (TACE) to Reduce the Recurrence in Hepatocellular Carcinoma (HCC) Patients at High Risk After Resection

Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. The conventional risk factors of recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after hepatectomy. The investigators' previous study showed that the recurrence rate is more than 50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only independent risk factor for the overall and disease-free survival of HCC patients in multiple variables analysis. It is important to reduce the recurrence and prolong the survival of patients after hepatectomy with effective adjuvant therapy. TACE has been utilized as an adjuvant therapy after hepatectomy, but its significance is still unknown. Then, the investigators design the current prospective randomized clinical trial to evaluate the effect of adjuvant TACE to reduce the recurrence in HCC patients at high risk (>5cm solitary tumor and MVI) after resection, compared to vigilant follow-up.

Read the detailed description

The patients with solitary tumor more than 5cm and microvessels invasion after radical hepatectomy were randomized to receive adjuvant TACE（1~2 cycles, 4~6 weeks) or follow-up. The main endpoint: overall survival (OS), disease-free survival(DFS), and safety were compared between this two groups.

Being tested
Adjuvant TACE, Follow-up
Keywords
Carcinoma,Hepatocellular, Chemoembolization, Adjuvant therapy, Hepatocellular, Microvessels invasion
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Adjuvant TACEProcedure or surgery

    1~2 cycles TACE were performed as adjuvant therapy after radical hepatectomy

  • Follow-upProcedure or surgery

    Patients received just follow-up to monitor the recurrence of HCC

Study groups in NCT02788526
Study groupRoleWhat they receive
Adjuvant TACEExperimentalAdjuvant TACE were performed 4-6 weeks after surgery
Receives: Procedure: Adjuvant TACE
Follow-upOtherRoutine follow-up were performed instead of adjuvant TACE
Receives: Procedure: Follow-up

What is being measured

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

  1. Overall survival

    The overall survival is defined as the percentage of patients who are alive at 5 years after their enrollments of this study.

    Measured: 5 years

Secondary outcomes (2)

  1. Disease-free survival

    The disease-free survival is defined as the percentage of patients who are alive at 5 years without any signs or symptoms of HCC after their enrollments of this study.

    Measured: 5 years

  2. Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 5 years

Timeline

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

  1. First posted2 Jun 2016 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2012
  4. Study completionJun 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02788526
Sponsor's protocol ID
SYSUCC-HCC-ADTACE
Status last verified
Jun 2016
First submitted
23 Mar 2016
Last updated
20 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1.

    PubMed 19408012

  • Li JQ, Zhang YQ, Zhang WZ. [Evaluation of chemoembolization as an adjuvant therapy for primary liver carcinoma after surgical resection]. Zhonghua Zhong Liu Za Zhi. 1994 Sep;16(5):387-9. Chinese.

    PubMed 7895595

  • Li JQ, Zhang YQ, Zhang WZ, Yuan YF, Li GH. Randomized study of chemoembolization as an adjuvant therapy for primary liver carcinoma after hepatectomy. J Cancer Res Clin Oncol. 1995;121(6):364-6. doi: 10.1007/BF01225689.

    PubMed 7541051

  • Peng B, Liang L, He Q, Zhou F, Luo S. Surgical treatment for hepatocellular carcinoma with portal vein tumor thrombus. Hepatogastroenterology. 2006 May-Jun;53(69):415-9.

    PubMed 16795984

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvant TACE and Follow-up in people with Carcinoma, Hepatocellular, run by Sun Yat-sen University at 1 site in China.

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 9 inclusion and 10 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: finished, as of the sponsor's last update on 20 Jun 2016. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (time frame: 5 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 NCT02788526, which also lists 4 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 20 Jun 2016.

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