Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing

NCT05520788 | Recruiting

• 1 other identifier: TJ-IRB20220129
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Exploring the precise medicine of patients with primary hepatobiliary cancer. And evaluate the efficacy and safety of individualized treatment regimens for primary hepatobiliary cancer based on next-generation sequencing.

Conditions

Hepatocellular Carcinoma; Biliary Tract Cancer

Keywords

Liver Neoplasms; Biliary Tract Neoplasms; NGS

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Time of progression will be obtained by telephone interview or medical treatment records.

  From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 year

Secondary Outcomes (6)

• Overall Survival (OS)

  2 years

• Objective response rates (ORR)

  From treatment initiation to CR or PR, up to 2 years

• Disease Control Rate (DCR)

  From treatment initiation to SD, CR or PR, up to 2 years

• Duration of Response (DOR)

  From treatment initiation to PD, up to 2 years

• Adverse Drug Reaction (ADR)/Adverse Event (AE)

  Through study completion, an average of 2 years.

Study Arms (1)

Precise medicine

All patients should accept next-generation sequencing (NGS) test before treatment.

Genetic: precise medicine

Interventions

precise medicine GENETIC

During screening stage, all patients should accept next-generation sequencing (NGS) test.

Precise medicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed primary hepatobiliary cancer in Tongji Hospital, Wuhan with results of NGS tests.

You may qualify if:

• Age from 18 to 65, male or female.
• Radiologically and pathologically confirmed as hepatobiliary cancers with stage IV.
• Palliative care as the preferred.
• The result of next-generation sequencing (NGS) test show the patient has gene mutation and also can be treated by the right commercial products that have been approved by the China Food and Drug Administration (CFDA) or the Food and Drug Administration (FDA).
• ECOG performance status 0-2.
• Life expectancy ≥3 months.
• Agree to sign informed consent form.

You may not qualify if:

• Hepatobiliary cancer patient with stageI-III, or with any of the following items will not be eligible for screening. Such as, suitable for the treatment of radical resection, radical resection but evaluation unmeasurable.
• The result of NGS test show the patient has no gene mutation, or has gene mutation but no medicine.
• ECOG performance status ≥ 3.
• Female patients who are pregnant or not using a contraceptive method of birth control.
• History or presence of serious cardiovascular or cerebrovascular abnormalities.
• Abnormalities of the hepatic or renal functions, such as jaundice, ascites, bilirubin ≥ 1.5×ULN, alkaline phosphatase ≥ 3×ULN, persistent protein urine≥ grade 3 (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTC-AE\] v4.0), creatinine ratio \> 3.5g/24 hours, renal failure.
• Persistent infection \> grade 2 (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTC-AE\] v4.0).
• Patient has underwent a major operation 4 weeks prior to screening or has not yet recovered from the operation.
• Patient with epilepsy, known or untreated brain metastases.
• The presence of wounds, ulcers or fractures that can not be healed, or with a past history of transplantation.
• The presence of bleeding events ≥grade 3 (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTC-AE\] v4.0) , present evidence or past history of coagulation dysfunction disorders.
• Known human immunodeficiency virus (HIV) infection history.
• Patient with drug abuse or unstable compliance.
• The presence of unresolved toxicity caused by any previous treatment/operation \> grade 1 (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTC-AE\] v4.0), except alopecia, anemia or hypothyroidism).
• Investigator consider that the patient should not be enrolled in this study by careful assessment.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The samples, both tissue(s) and blood of patients should be provided for the High-Throughput Sequencing test before screening.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Biliary Tract Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Diseases

Study Officials

• Wanguang Zhang

  Tongji Hospital

  STUDY CHAIR

• Zeyang Ding

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bixiang Zhang, PhD

CONTACT

86-027-83665293; bixiangzhang@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: August 30, 2022
• Study Start: May 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)