The Treatment and Prognosis of Primary Hepatobiliary Cancer: A Cohort Study in Central China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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
结局指标
主要结局
Overall Survival (OS)
时间窗: 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.
Progression-free survival (PFS)
时间窗: 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Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
Duration of Response (DOR)
时间窗: 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
Disease Control Rate (DCR)
时间窗: 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
Objective response rates (ORR)
时间窗: From treatment initiation to CR or PR, up to 2 years
Percentage of patients whose tumors have a complete or partial response to treatment.
次要结局
- 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)
- 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)
- 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)
研究者
Zhang Bi Xiang, MD
Chairman of Department of General Surgery
Tongji Hospital