Primary Hepatobiliary Cancer Cohort of Central China (CCGLC-002)

December 13, 2023 updated by: Zhang Bi Xiang, MD, Tongji Hospital

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who diagnosed as primary hepatobiliary cancer.

Description

Inclusion Criteria:

  1. ≥18 years old,
  2. life expectancy is at least 6 months.
  3. 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).
  4. At least one measurable lesion (RECIST v1.1)
  5. Subjects volunteer to participate in the study and sign informed consent.

Exclusion Criteria:

Patients with one or more of the following criteria should be excluded:

  1. CT or MRI shows no measurable lesions (RECIST v1.1).
  2. Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.
  3. Incomplete baseline or follow-up data
  4. Suffering from more than two kinds of primary tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From treatment initiation to SD, CR or PR, up to 2 years
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.
From treatment initiation to CR or PR, up to 2 years
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.
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)
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
From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 years
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
From treatment initiation to PD, up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 recurrence will be obtained by telephone interview or medical treatment records
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
Time of metastasis will be obtained by telephone interview or medical treatment records
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Gelesis, Inc.
Geneplus-Beijing Co. Ltd.
Chinese Cooperative Group of Liver Cancer (CCGLC)
Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province
Haplox Biotechnology Co., Ltd.
YuceBio Technology

Investigators

  • Principal Investigator: Zeyang Ding, Tongji Hospital
  • Study Chair: Bixiang Zhang, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

August 28, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20210935

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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