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.
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
2,000
Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGOverall Survival (OS)
Time of death will be obtained by telephone interview or medical treatment records.
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
Progression-free survival (PFS)
Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From treatment initiation to CR or PR, up to 2 years
Time of recurrence
Time of recurrence will be obtained by telephone interview or medical treatment records
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
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Time of metastasis
Time of metastasis will be obtained by telephone interview or medical treatment records
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
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.
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