Primary Hepatobiliary Cancer Cohort of Central China

NCT05520801 | Unknown

• 1 other identifier: TJ-IRB20210935
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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 treatment since 1998.

Conditions

Hepatocellular Carcinoma; Biliary Tract Neoplasms

Keywords

Primary Hepatobiliary Cancer

Outcome Measures

Primary Outcomes (5)

• Overall Survival (OS)

  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)

  Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date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

• 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

  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

  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.

  From treatment initiation to CR or PR, up to 2 years

Secondary Outcomes (3)

• Time of recurrence

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed as primary hepatobiliary cancer.

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead
• Chinese Cooperative Group of Liver Cancer: collaborator
• Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province: collaborator
• Haplox Biotechnology Co., Ltd.: collaborator
• Geneplus-Beijing Co. Ltd.: collaborator
• YuceBio Technology: collaborator
• Gelesis, Inc.: collaborator

Study Sites (1)

Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, urine, feces, ascites, bile samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Diseases

Study Officials

• Bixiang Zhang

  Tongji Hospital

  STUDY CHAIR

• Zeyang Ding

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bixiang Zhang, PhD

CONTACT

86-027-83665293; bixiangzhang@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of General Surgery

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: August 30, 2022
• Study Start: May 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

CN (1)