Primary Hepatobiliary Cancer Cohort of Central China

Hepatocellular Carcinoma Clinical Trial

— CCGLC-002  

Official title:

The Treatment and Prognosis of Primary Hepatobiliary Cancer: A Cohort Study in Central China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520801
• Other study ID #: TJ-IRB20210935
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: December 2023
• Source: Tongji Hospital
• Contact: Bixiang Zhang, PhD
• Phone: 86-027-83665293
• Email: bixiangzhang[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 treatment since 1998.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Time of recurrence	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
Secondary	Time of metastasis	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
Secondary	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.	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