Hepatocellular Carcinoma Registry in Asia

• Sponsor: National Cancer Centre, Singapore (Other)
• Overall Status: Completed
• CT.gov ID: NCT03233360
• Collaborator: Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group (Other), Singapore Clinical Research Institute (Other), Iqvia Pty Ltd (Industry)
• Enrollment: 2,537
• Locations: 34
• Actual Duration (Months): 44.5
• Patients Per Site: 74.6
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 30th June 2018 in nine countries (ie, Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30% of the sample size will be identified retrospectively and 70% will be identified prospectively from the start date of the registry (October 2016), with an even distribution of consecutively diagnosed patients within the different years.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma

Study Design

• Study Type: Observational
• Actual Enrollment: 2537 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Hepatocellular Carcinoma Registry in Asia
• Actual Study Start Date: Apr 17, 2017
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Overall Survival [From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years]

2. Progression-free survival [From treatment initiation for advanced or metastatic HCC to the first date of disease progression or death due to any cause, whichever occurred first, up to 2 years]

   Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date

3. Time to progression [From the start of treatment for a disease until disease progression, up to 2 years]

   Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.

4. Overall Survival Rate [5 years from date of diagnosis]

   The percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment. Also called survival rate.

5. Best Overall Response Rate (BORR) [From treatment initiation to CR or PR, up to 2 years]

   The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC

6. Disease Control Rate (DCR) [From treatment initiation to SD, CR or PR, up to 2 years]

   The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC

7. Disease Free Survival (DFS) [From the time from completing adjuvant/neoadjuvant treatment to the date of HCC recurrence, or the date of death due to any cause, whichever occurred first, up to 2 years]

   Patients lost for follow up will be censored at the last disease assessment date; DFS rate at 2 years - defined as the proportion of HCC patients who are alive and cancer free 2 years after completion of adjuvant/neoadjuvant treatment

8. Recurrence rate [From the time from a CR to treatment to the first recurrence of HCC, up to 2 years]

   The proportion of patients who experience a recurrence of HCC after having had a CR to treatment

9. Sites of recurrence [From the time from a CR to treatment to the first recurrence of HCC, up to 2 years]

   local/ regional / distant; specify site(s)

10. Time to treatment recurrence [From the time from a CR to treatment to the first recurrence of HCC, up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female or male aged 21 or above.

• Patient with confirmed diagnosis of HCC between 1st January 2013 and 30th June 2018 based on one or more of the following criteria:

• American Association for the Study of Liver Diseases (AASLD) criteria

• Asian Pacific Association for the Study of the Liver (APASL) criteria

• Histology/cytology

• Space occupying lesion in the liver and an serum alpha-feto protein of > 400 in a patient with chronic viral hepatitis or cirrhosis from any cause

• Informed consent form (ICF) to be presented and signed by patients who are still alive at the point of study enrolment, per local regulations. For the collection of data for deceased subjects, appropriate waiver of consent as per local regulations and guidelines will have to be in place.

• Patient who is being followed-up at the participating site.

Exclusion Criteria:

• Patients participating in any HCC-related therapeutic/interventional clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
2	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
3	Flinders Medical Centre	Bedford Park	South Australia	Australia	SA 5042
4	Beijing Cancer Hospital	Beijing	Beijing	China	100142
5	Southwest Hospital of Third Military Medical University	Chongqing	Chongqing	China	400000
6	Guangxi Medical University Cancer Center	Nanning	Guangxi	China	530021
7	Nanjing Bayi Hospital	Nanjing	Jiangsu	China	210002
8	Zhongshan Hospital	Shanghai	Shanghai	China	200032
9	Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009
10	Queen Mary Hospital	Hong Kong		Hong Kong
11	Kinki University School of Medicine	Ōsakasayama	Osaka	Japan	589-8511
12	National Cancer Centre, Japan	Chūōku	Tokyo	Japan	104-0045
13	Kyorin University School of Medicine	Mitaka-shi	Tokyo	Japan	181-8611
14	University of Tokyo	Tokyo		Japan
15	St Vincent Hospital, Catholic University Medical College	Gyeonggi-do		Korea, Republic of	16247
16	Ajou University Hospital	Gyeonggi-do		Korea, Republic of	16499
17	Seoul National University Bundang Hospital	Gyeonggi-do		Korea, Republic of
18	Asan Medical Centre	Seoul		Korea, Republic of	05505
19	St. Mary's Hospital	Seoul		Korea, Republic of	131-701
20	Korea University Anam Hospital	Seoul		Korea, Republic of
21	Samsung Medical Center	Seoul		Korea, Republic of
22	Severance Hospital, Yonsei University College of Medicine	Seoul		Korea, Republic of
23	Auckland City Hospital	Grafton	Auckland	New Zealand	1023
24	National University Hospital	Singapore		Singapore	119074
25	Singapore General Hospital	Singapore		Singapore	169608
26	National Cancer Centre	Singapore		Singapore	169610
27	China Medical University Hospital	Taichung		Taiwan	40402
28	National Cheng Kung University Hospital	Tainan		Taiwan
29	Chang Gung Memorial Hospital-KS	Taipei		Taiwan
30	National Taiwan University Hospital	Taipei		Taiwan
31	Taipei Veterans General Hospital	Taipei		Taiwan
32	Chulabhorn Hospital	Bang Khen	Bangkok	Thailand	10210
33	Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok	Thailand	10700
34	National Cancer Institute	Ratchathewi	Bangkok	Thailand	10400

Sponsors and Collaborators

• National Cancer Centre, Singapore
• Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group
• Singapore Clinical Research Institute
• Iqvia Pty Ltd

Investigators

• Principal Investigator: Pierce Chow, MD, PhD, National Cancer Centre, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Centre, Singapore
• ClinicalTrials.gov Identifier: NCT03233360
• Other Study ID Numbers: AHCC08
• First Posted: Jul 28, 2017
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Feb 21, 2021