Primary Hepatobiliary Cancer Cohort of Central China

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma, Biliary Tract Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Hepatobiliary Cancer