An observational study in Hepatocellular Carcinoma and Biliary Tract Neoplasms, sponsored by Tongji Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Tongji Hospital · Observational
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.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 160 across 67 observational studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who diagnosed as primary hepatobiliary cancer.
Exclusion Criteria:
Patients with one or more of the following criteria should be excluded:
Overall 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Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date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
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Tongji Hospital