Biliary Tract Neoplasms, Hepatocellular Carcinoma
Conditions
Keywords
Primary Hepatobiliary Cancer
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.
Detailed 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.
Interventions
None listed
Sponsors
Chinese Cooperative Group of Liver Cancer
Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province
Haplox Biotechnology Co., Ltd.
Geneplus-Beijing Co. Ltd.
YuceBio Technology
Gelesis, Inc.
Tongji Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rates (ORR) | From treatment initiation to CR or PR, up to 2 years | Percentage of patients whose tumors have a complete or partial response to treatment. |
| Progression-free survival (PFS) | From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 years | Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date |
| Disease Control Rate (DCR) | From treatment initiation to SD, CR or PR, up to 2 years | The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC |
| Duration of Response (DOR) | From treatment initiation to PD, up to 2 years | 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 |
| Overall Survival (OS) | From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years | Time of death will be obtained by telephone interview or medical treatment records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Time of metastasis will be obtained by telephone interview or medical treatment records |
| 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 | 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 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 recurrence will be obtained by telephone interview or medical treatment records |
Countries
China
Contacts
Primary ContactBixiang Zhang, PhD
Outcome results
None listed