Hepatocellular CarcinomaCCGLC-002NCT05520801
Primary Hepatobiliary Cancer Cohort of Central China
An observational study of Hepatocellular Carcinoma and Biliary Tract Neoplasms, run by Tongji Hospital at 1 site in China.
Trial summary
This registry is designed as a longitudinal cohort study of patients diagnosed with primary hepatobiliary cancer in Tongji Hospital, Wuhan. This study collects the clinical-pathological features of hepatic malignant tumors and the current status of patients who received comprehensive treatment based on surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Biliary Tract Neoplasms
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Mar 2025
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who diagnosed as primary hepatobiliary cancer.
Who may be able to join
- ≥18 years old,
- life expectancy is at least 6 months.
- Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or confirmed by imaging as HCC (by the AASLD or guidance for the diagnosis and treatment of primary liver cancer of China (version 2022).
- At least one measurable lesion (RECIST v1.1)
- Subjects volunteer to participate in the study and sign informed consent.
Who cannot join
- Patients with one or more of the following criteria should be excluded:
- CT or MRI shows no measurable lesions (RECIST v1.1).
- Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.
- Incomplete baseline or follow-up data
- Suffering from more than two kinds of primary tumors
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ze-yang Ding, M.D., +8613407156200, dingzyang@sina.com
About this study
Official title: The Treatment and Prognosis of Primary Hepatobiliary Cancer: A Cohort Study in Central China
This registry is designed as a longitudinal cohort study of patients diagnosed with primary hepatobiliary cancer in Tongji Hospital, Wuhan. This study collects the clinical-pathological features of hepatic malignant tumors and the current status of patients who received comprehensive treatment based on surgical treatment since 1998.
Read the detailed description
This longitudinal observational cohort study was designed to make standardized settlements, statistical treatments, and comprehensive analysis of primary hepatobiliary cancers in middle China, which summarize and estimate the population, tumor staging, treatment mode, clinical-pathological characteristics, and the prognosis, to provide evidence for standardized treatment of hepatobiliary cancers.
- Conditions
- Hepatocellular Carcinoma, Biliary Tract Neoplasms
- Keywords
- Primary Hepatobiliary Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Biliary Tract Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time of death will be obtained by telephone interview or medical treatment records.
Measured: From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
Progression-free survival (PFS)
Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
Measured: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 years
Disease Control Rate (DCR)
The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC
Measured: From treatment initiation to SD, CR or PR, up to 2 years
Duration of Response (DOR)
DOR is the duration from the first assessment of the tumor was CR or PR to the time that the first assessment for PD or date of death from any cause
Measured: From treatment initiation to PD, up to 2 years
Objective response rates (ORR)
Percentage of patients whose tumors have a complete or partial response to treatment.
Measured: From treatment initiation to CR or PR, up to 2 years
Secondary outcomes (3)
Time of recurrence
Time of recurrence will be obtained by telephone interview or medical treatment records
Measured: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years
Time of metastasis
Time of metastasis will be obtained by telephone interview or medical treatment records
Measured: From date of diagnosis until the date of cancer metastasis or date of death from any cause, whichever came first, assessed up to 10 years
Quality of Life (QoL) after treatment
Life quality of every subject will be assessed every 3 months according to the FACT-Hep questionnaire, which assesses generic HRQL concerns and disease-specific issues.
Measured: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Cooperative Group of Liver Cancer, Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province, Haplox Biotechnology Co., Ltd., Geneplus-Beijing Co. Ltd., YuceBio Technology, Gelesis, Inc.
- Responsible party
- Principal investigator, Zhang Bi Xiang, MD, Tongji Hospital
- Investigators
- Bixiang Zhang, Study chair, Tongji HospitalZeyang Ding, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520801
- Sponsor's protocol ID
- TJ-IRB20210935
- Acronym
- CCGLC-002
- Status last verified
- Dec 2023
- First submitted
- 23 Jan 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment and Prognosis of Primary Hepatobiliary Cancer: A Cohort Study in Central China
- ClinicalTrials.gov ID
- NCT05520801
- Acronym / sponsor ID
- CCGLC-002 / TJ-IRB20210935
- Conditions
- Hepatocellular Carcinoma, Biliary Tract Neoplasms
- Keywords
- Primary Hepatobiliary Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Chinese Cooperative Group of Liver Cancer, Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province, Haplox Biotechnology Co., Ltd., Geneplus-Beijing Co. Ltd., YuceBio Technology, Gelesis, Inc.
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This registry is designed as a longitudinal cohort study of patients diagnosed with primary hepatobiliary cancer in Tongji Hospital, Wuhan. This study collects the clinical-pathological features of hepatic malignant tumors and the current status of patients who received comprehensive treatment based on surgical treatment since 1998.
Detailed description
This longitudinal observational cohort study was designed to make standardized settlements, statistical treatments, and comprehensive analysis of primary hepatobiliary cancers in middle China, which summarize and estimate the population, tumor staging, treatment mode, clinical-pathological characteristics, and the prognosis, to provide evidence for standardized treatment of hepatobiliary cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed as primary hepatobiliary cancer.
Key inclusion criteria (5 listed)
- ≥18 years old,
- life expectancy is at least 6 months.
- Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or confirmed by imaging as HCC (by the AASLD or guidance for the diagnosis and treatment of primary liver cancer of China (version 2022).
- At least one measurable lesion (RECIST v1.1)
- Subjects volunteer to participate in the study and sign informed consent.
Key exclusion criteria (5 listed)
- CT or MRI shows no measurable lesions (RECIST v1.1).
- Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.
- Incomplete baseline or follow-up data
- Suffering from more than two kinds of primary tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
Time of death will be obtained by telephone interview or medical treatment records.
Progression-free survival (PFS)
Time frame: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 years
Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
Disease Control Rate (DCR)
Time frame: 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
Duration of Response (DOR)
Time frame: From treatment initiation to PD, up to 2 years
DOR is the duration from the first assessment of the tumor was CR or PR to the time that the first assessment for PD or date of death from any cause
Objective response rates (ORR)
Time frame: From treatment initiation to CR or PR, up to 2 years
Percentage of patients whose tumors have a complete or partial response to treatment.
3 secondary outcomes
Time of recurrence
Time frame: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years
Time of metastasis
Time frame: From date of diagnosis until the date of cancer metastasis or date of death from any cause, whichever came first, assessed up to 10 years
Quality of Life (QoL) after treatment
Time frame: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bixiang Zhang study chair
Tongji Hospital
Zeyang Ding principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Biliary Tract Neoplasms, run by Tongji Hospital 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 5 inclusion and 5 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 19 Dec 2023. 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.
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?
Contact Bixiang Zhang, PhD (86-027-83665293, bixiangzhang@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2023.