Clinical trial NCT04445532: Hepatobiliary Tumors Tissue Samples Acquisition
Official title: Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Cholangiocarcinoma
Gallbladder Cancer
Biliary Tract Cancer
Liver Cancer
Precancerous Condition
Benign Hepatobiliary Disease
Healthy, no Evidence of Disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: OrigiMed
name: GeneCast Biotechnology Co., Ltd.
name: YuceBio Technology Co., Ltd.
name: Geneplus-Beijing Co. Ltd.
First posted: 2020-06-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatobiliary cancer, benign hepatobiliary disease, and healthy Subjects will be recruited at Peking Union Medical College Hospital.

Brief summary: Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of great significance to find important prognostic markers and then screen out specific subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control participants also need to show the evolution of tumors and discover specific diagnostic markers as a control group. Moreover, targeted therapy and immunotherapy make cancer treatment enter a new field, but only part of patients achieve response rates and reach clinical benefit. However, these drugs are expensive and can cause treatment-related adverse events. Therefore, reliable biomarkers identification is needed to help predict the response to these treatment options in order to screen patients with better responsiveness and avoid wasting money. Multi-omics research can reveal the characteristics of hepatobiliary tumors more deeply and find meaningful therapeutic targets.

Therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in this study.

Detailed description: OBJECTIVES:

1. Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival (OS);
2. Observe the evolution of tumors and discover specific diagnostic markers as a control group.
3. Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted immunotherapy for advanced hepatobiliary tumors;
4. To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and find therapeutic targets

Eligibility criteria: Inclusion Criteria:

1. Be older than 18 years old;
2. ECOG 0-2 points;
3. May have received treatment;
4. Clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or chronic hepatitis, cirrhosis, or healthy control participants;
5. Patients may have received or are about to undergo surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy, etc.;
6. Patients understand and are willing to sign written informed consent documents.

Exclusion Criteria:

1. The doctor thinks it is not suitable to enter the group (mental disorder or poor compliance, etc.)
2. Pregnant women;
3. Active or uncontrollable infections (fungi, bacteria, etc.);
4. Estimated survival time \<12 weeks;
5. If the patient is receiving chronic anticoagulant therapy, the anticoagulant withdrawal should not be shorter than 3 days;
6. In the evaluation of the doctor, there is a risk of uncontrolled complications in the biopsy.

Primary outcomes:
measure: Collected samples
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS)
timeFrame: through study completion, an average of 5 years
measure: Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors
timeFrame: through study completion, an average of 5 years
measure: Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors
timeFrame: through study completion, an average of 5 years
measure: Multi-omics analysis to further type and find therapeutic targets
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Haitao Zhao, MD
role: PRINCIPAL_INVESTIGATOR
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