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Hepatobiliary Tumors Tissue Samples Acquisition

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Enrolling

Conditions

Gallbladder Cancer
Benign Hepatobiliary Disease
Biliary Tract Cancer
Healthy, no Evidence of Disease
Precancerous Condition
Hepatocellular Carcinoma
Cholangiocarcinoma
Liver Cancer

Treatments

Other: Immunohistochemistry
Other: Protein expression analysis
Other: Proteomic profiling
Other: Methylation and epigenetic analysis
Other: Genomic analysis
Other: Mass spectrometry
Other: Polymerase chain reaction
Other: Metabolomics profiling
Other: Gene expression analysis
Other: Laboratory biomarker analysis
Other: Liquid biopsy analysis

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04445532
JS-2296

Details and patient eligibility

About

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.

Full 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
Read more

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

450 participants in 2 patient groups

hepatobiliary tumor patients
Description:
benign or malignant hepatobiliary tumors patients
Treatment:
Other: Immunohistochemistry
Other: Liquid biopsy analysis
Other: Proteomic profiling
Other: Genomic analysis
Other: Polymerase chain reaction
Other: Metabolomics profiling
Other: Gene expression analysis
Other: Protein expression analysis
Other: Mass spectrometry
Other: Methylation and epigenetic analysis
Other: Laboratory biomarker analysis
Benign Hepatobiliary Disease
Description:
chronic hepatitis, cirrhosis, and healthy control
Treatment:
Other: Immunohistochemistry
Other: Liquid biopsy analysis
Other: Proteomic profiling
Other: Genomic analysis
Other: Polymerase chain reaction
Other: Metabolomics profiling
Other: Gene expression analysis
Other: Protein expression analysis
Other: Mass spectrometry
Other: Methylation and epigenetic analysis
Other: Laboratory biomarker analysis

Trial contacts and locations

1

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Central trial contact

Haitao Zhao, MD; XiaoBo Yang, MD

Data sourced from clinicaltrials.gov

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