AzTrials
AzTrials

Hepatocellular Carcinoma ResectableNCT06294808

Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC

An observational study of Hepatocellular Carcinoma Resectable, run by National Cancer Centre, Singapore at 2 sites in Singapore.

Completed

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

Official record
Search all trials

Trial summary

Clinical outcomes after surgical resection in HCC is a continuum and is clearly related to tumor burden but needs better definition. The researchers describe the use of the "metro ticket" approach to analyze surgical outcomes over the whole spectrum of anatomically resectable HCC to define overall survival including… Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Hepatocellular Carcinoma Resectable
How many people
1,043 participants
Where
2 sitesSingapore
Study dates
17 Jul 2017to 30 Jun 2020
Phase
Observational
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 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent surgical resection (both open surgery and laparoscopic surgery) for HCC from 1st January 2000 to 30th June 2018 by the joint hepato-pancreato-biliary surgery service at the Singapore Healthcare Group of Hospitals (Singapore General Hospital and the National Cancer Centre Singapore).

Who may be able to join

  • Unequivocal diagnosis of Hepatocellular Carcinoma (HCC) by histology
  • Patients who underwent surgical resection for HCC

Who cannot join

  • Patients who underwent liver resection for other malignancies ie cholangiocarcinoma
  • Patients with HCC who did not undergo liver resection.
  • Patients with HCC who underwent liver transplant.

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites
  • National Cancer Centre, Singapore

    Singapore, 168583

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

Official title: Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC: a Metroticket Approach

Clinical outcomes after surgical resection in HCC is a continuum and is clearly related to tumor burden but needs better definition. The researchers describe the use of the "metro ticket" approach to analyze surgical outcomes over the whole spectrum of anatomically resectable HCC to define overall survival including intermediate stage tumors (BCLC B). The analysis the researchers provide in this study enables the clinician to select the optimal surgical resection candidate based on robust long term survival data.

In addition, study compares outcome for open surgery vs laparoscopic surgery, survival outcome for viral and non-viral HCC using Albumin-Bilirubin (ALBI) for more comprehensive study result.

Read more

On top of that, non-HBV, non-HCV (NBNC) hepatocellular carcinoma (HCC) is generally associated with poorer tumor characteristics. However, it remains unclear whether this leads to worse post-resection survival compared to viral-related HCC. This study evaluates the prognostic impact of viral status and liver function on post-resection survival outcomes between NBNC and viral HCC patients.

This retrospective study also aims to determine if HCC of viral and non-viral etiologies have different clinical outcomes after surgical resection when tumor burden and liver function are considered.

Read the detailed description

Patients who underwent surgical resection (both open surgery and laparoscopic surgery) for HCC from 1st January 2000 to 30th June 2018 by the joint hepato-pancreato-biliary surgery service at the Singapore Healthcare Group of Hospitals (Singapore General Hospital and the National Cancer Centre Singapore) were retrospectively identified from a prospectively kept institutional database.

The assessment of the size, number of nodules and vascular invasion of HCC were based on pre-operative CT/MRI imaging and pathological assessment of the resected specimens. All resections were histologically confirmed as HCC. Patients with macrovascular invasion and extrahepatic invasion were excluded from analysis as were patients resected for other palliative intents (e.g. ruptured HCC).

Keywords
Metroticket Approach, Surgical Resection, Hepatocellular Carcinoma (HCC)
Medical subject headings
Carcinoma, Hepatocellular

What is being measured

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

  1. 5-year mortality.

    Time between the respective surgery to the time of death. Bivariate contour plots of 5-year survival probability as a function of X = AFP concentration (ng/mL) and Y = tumor burden index (size of largest nodule + 2*number of nodules) (TBI) were obtained as smoothed contours originating from an empirically-derived bivariate 5-year survival distribution S(X,Y)=1- F(x ≤X,y ≤Y). The function F(x ≤X,y ≤Y) is the empirical, bivariate cumulative distribution of 5-year mortality as a function of X and Y defined over the domain (0<X≤5000,1≤Y≤15) in our patient cohort. All patients in our study cohort were followed up for at least 5 years following respective surgery which allowed estimation of actual all-cause 5-year mortality.

    Measured: At least 5 years.

  2. Concordance of pre-operative radiological and post operative surgical specimen.

    The metro ticket modeling was based on tumour size and number of nodules extracted at pre-operative radiological imaging and post surgical pathology assessment. Continuous variables are summarized as mean, standard deviation, 25th and 75th percentiles, median and minimum and maximum. Categorical variables are summarized as counts (N) and percentages (%).

    Measured: Through study completion, an average of 3 years.

  3. Agreement between TBI calculated from pre-operative imaging versus those obtained from post-surgical pathological assessment.

    Bland-Altman analysis, which is based on a simple but effective graphical approach for evaluating bias and for calculating bounds on the expected magnitude of the individual differences arising between the two measurement methods, is used. A 45° line of identity with scatter plot was produced to display the correlation between the 2 measurements. Bias was evaluated by calculating (d) ̅ the mean difference of the measurements. Limits of agreement, calculated as (d) ̅ ±2sd , where sd is the standard deviation of the individual differences, defined bounds within which 95% of the measurement differences are expected to fall. The B-A plot defines the limits of agreements. B-A analysis is performed using TBI over a wide range, 0 ≤ TBI ≤ 30, and a restricted range focusing on small tumors, 0 < TBI ≤ 6.

    Measured: Through study completion, an average of 3 years.

  4. Overall survival (OS) stratified on hepatitis status.

    The time elapsed from the surgical resection to the point of death or the last follow-up, whichever occurred first.

    Measured: Minimum 2 years follow up after Hepatocellular carcinoma resection.

  5. Recurrence-free survival (RFS) stratified on hepatitis status.

    The time between surgical resection of HCC and its recurrence confirmed via multi-phasic CT or MRI imaging, or last follow-up, whichever occurred first.

    Measured: Minimum 2 years follow up after Hepatocellular carcinoma resection.

  6. Prognostic stratification according to ALBI grade.

    Overall survival (OS) and Recurrence-free survival (RFS) stratified according to ALBI grade.

    Measured: Minimum 2 years follow up after Hepatocellular carcinoma resection.

Timeline

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

  1. First posted6 Mar 2024
  2. Study start17 Jul 2017
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
1,043 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06294808
Sponsor's protocol ID
2017-2601
Status last verified
Nov 2025
First submitted
26 Feb 2024
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

    PubMed 21351269
  • Omata M, Lesmana LA, Tateishi R, Chen PJ, Lin SM, Yoshida H, Kudo M, Lee JM, Choi BI, Poon RT, Shiina S, Cheng AL, Jia JD, Obi S, Han KH, Jafri W, Chow P, Lim SG, Chawla YK, Budihusodo U, Gani RA, Lesmana CR, Putranto TA, Liaw YF, Sarin SK. Asian Pacific Association for the Study of the Liver consensus recommendations on hepatocellular carcinoma. Hepatol Int. 2010 Mar 18;4(2):439-74. doi: 10.1007/s12072-010-9165-7.

    PubMed 20827404
  • Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.

    PubMed 20180029
  • Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.

    PubMed 22353262
  • Lim KC, Chow PK, Allen JC, Siddiqui FJ, Chan ES, Tan SB. Systematic review of outcomes of liver resection for early hepatocellular carcinoma within the Milan criteria. Br J Surg. 2012 Dec;99(12):1622-9. doi: 10.1002/bjs.8915. Epub 2012 Sep 28.

    PubMed 23023956
  • Mazzaferro V, Llovet JM, Miceli R, Bhoori S, Schiavo M, Mariani L, Camerini T, Roayaie S, Schwartz ME, Grazi GL, Adam R, Neuhaus P, Salizzoni M, Bruix J, Forner A, De Carlis L, Cillo U, Burroughs AK, Troisi R, Rossi M, Gerunda GE, Lerut J, Belghiti J, Boin I, Gugenheim J, Rochling F, Van Hoek B, Majno P; Metroticket Investigator Study Group. Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis. Lancet Oncol. 2009 Jan;10(1):35-43. doi: 10.1016/S1470-2045(08)70284-5. Epub 2008 Dec 4.

    PubMed 19058754
  • Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.

    PubMed 21374666
  • Zhong JH, Ke Y, Gong WF, Xiang BD, Ma L, Ye XP, Peng T, Xie GS, Li LQ. Hepatic resection associated with good survival for selected patients with intermediate and advanced-stage hepatocellular carcinoma. Ann Surg. 2014 Aug;260(2):329-40. doi: 10.1097/SLA.0000000000000236.

    PubMed 24096763
  • Lin CT, Hsu KF, Chen TW, Yu JC, Chan DC, Yu CY, Hsieh TY, Fan HL, Kuo SM, Chung KP, Hsieh CB. Comparing hepatic resection and transarterial chemoembolization for Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma: change for treatment of choice? World J Surg. 2010 Sep;34(9):2155-61. doi: 10.1007/s00268-010-0598-x.

    PubMed 20407768
  • Ng KK, Vauthey JN, Pawlik TM, Lauwers GY, Regimbeau JM, Belghiti J, Ikai I, Yamaoka Y, Curley SA, Nagorney DM, Ng IO, Fan ST, Poon RT; International Cooperative Study Group on Hepatocellular Carcinoma. Is hepatic resection for large or multinodular hepatocellular carcinoma justified? Results from a multi-institutional database. Ann Surg Oncol. 2005 May;12(5):364-73. doi: 10.1245/ASO.2005.06.004. Epub 2005 Mar 31.

    PubMed 15915370
  • Yang LY, Fang F, Ou DP, Wu W, Zeng ZJ, Wu F. Solitary large hepatocellular carcinoma: a specific subtype of hepatocellular carcinoma with good outcome after hepatic resection. Ann Surg. 2009 Jan;249(1):118-23. doi: 10.1097/SLA.0b013e3181904988.

    PubMed 19106686
  • Torzilli G, Belghiti J, Kokudo N, Takayama T, Capussotti L, Nuzzo G, Vauthey JN, Choti MA, De Santibanes E, Donadon M, Morenghi E, Makuuchi M. A snapshot of the effective indications and results of surgery for hepatocellular carcinoma in tertiary referral centers: is it adherent to the EASL/AASLD recommendations?: an observational study of the HCC East-West study group. Ann Surg. 2013 May;257(5):929-37. doi: 10.1097/SLA.0b013e31828329b8.

    PubMed 23426336
  • European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.

    PubMed 22424438
  • Ishizawa T, Hasegawa K, Aoki T, Takahashi M, Inoue Y, Sano K, Imamura H, Sugawara Y, Kokudo N, Makuuchi M. Neither multiple tumors nor portal hypertension are surgical contraindications for hepatocellular carcinoma. Gastroenterology. 2008 Jun;134(7):1908-16. doi: 10.1053/j.gastro.2008.02.091. Epub 2008 Mar 8.

    PubMed 18549877
  • Peng ZW, Guo RP, Zhang YJ, Lin XJ, Chen MS, Lau WY. Hepatic resection versus transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus. Cancer. 2012 Oct 1;118(19):4725-36. doi: 10.1002/cncr.26561. Epub 2012 Feb 22.

    PubMed 22359112

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma Resectable, run by National Cancer Centre, Singapore at 2 sites in Singapore.

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 2 inclusion and 3 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. 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.

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?

5-year mortality. (time frame: At least 5 years.). The study lists 6 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 NCT06294808, which also lists 31 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 18 Nov 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in