Clinical trial NCT05520801: Primary Hepatobiliary Cancer Cohort of Central China
Official title: The Treatment and Prognosis of Primary Hepatobiliary Cancer: A Cohort Study in Central China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Biliary Tract Neoplasms
Keywords: Primary Hepatobiliary Cancer
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Cooperative Group of Liver Cancer
name: Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province
name: Haplox Biotechnology Co., Ltd.
name: Geneplus-Beijing Co. Ltd.
name: YuceBio Technology
name: Gelesis, Inc.
First posted: 2022-08-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who diagnosed as 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
measure: Progression-free survival (PFS)
timeFrame: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: From treatment initiation to SD, CR or PR, up to 2 years
measure: Duration of Response (DOR)
timeFrame: From treatment initiation to PD, up to 2 years
measure: Objective response rates (ORR)
timeFrame: From treatment initiation to CR or PR, up to 2 years
Secondary outcomes:
measure: Time of recurrence
timeFrame: 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
measure: Time of metastasis
timeFrame: 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
measure: Quality of Life (QoL) after treatment
timeFrame: 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
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Bixiang Zhang
role: STUDY_CHAIR
affiliation: Tongji Hospital
name: Zeyang Ding
role: PRINCIPAL_INVESTIGATOR
References: