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

Last updated: February 9, 2025
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Biliary Tract Cancer

Cancer/tumors

Gall Bladder Cancer

Treatment

precise medicine

Clinical Study ID

NCT05520788
TJ-IRB20220129
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age from 18 to 65, male or female.

  2. Radiologically and pathologically confirmed as hepatobiliary cancers with stage IV.

  3. Palliative care as the preferred.

  4. The result of next-generation sequencing (NGS) test show the patient has genemutation and also can be treated by the right commercial products that have beenapproved by the China Food and Drug Administration (CFDA) or the Food and DrugAdministration (FDA).

  5. ECOG performance status 0-2.

  6. Life expectancy ≥3 months.

  7. Agree to sign informed consent form.

Exclusion

Exclusion Criteria:

  1. Hepatobiliary cancer patient with stageI-III, or with any of the following itemswill not be eligible for screening. Such as, suitable for the treatment of radicalresection, radical resection but evaluation unmeasurable.

  2. The result of NGS test show the patient has no gene mutation, or has gene mutationbut no medicine.

  3. ECOG performance status ≥ 3.

  4. Female patients who are pregnant or not using a contraceptive method of birthcontrol.

  5. History or presence of serious cardiovascular or cerebrovascular abnormalities.

  6. 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 forAdverse Events [CTC-AE] v4.0), creatinine ratio > 3.5g/24 hours, renal failure.

  7. Persistent infection > grade 2 (according to National Cancer Institute [NCI] CommonTerminology Criteria for Adverse Events [CTC-AE] v4.0).

  8. Patient has underwent a major operation 4 weeks prior to screening or has not yetrecovered from the operation.

  9. Patient with epilepsy, known or untreated brain metastases.

  10. The presence of wounds, ulcers or fractures that can not be healed, or with a pasthistory of transplantation.

  11. The presence of bleeding events ≥grade 3 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0) , presentevidence or past history of coagulation dysfunction disorders.

  12. Known human immunodeficiency virus (HIV) infection history.

  13. Patient with drug abuse or unstable compliance.

  14. The presence of unresolved toxicity caused by any previous treatment/operation >grade 1 (according to National Cancer Institute [NCI] Common Terminology Criteriafor Adverse Events [CTC-AE] v4.0), except alopecia, anemia or hypothyroidism).

  15. Investigator consider that the patient should not be enrolled in this study bycareful assessment.

  16. The subjects participate in any other clinical trial in the meantime.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: precise medicine
Phase:
Study Start date:
May 01, 2020
Estimated Completion Date:
December 31, 2025

Study Description

The purpose of this study is to explore the precise treatment in hepatobiliary cancer patients and evaluate drug efficacy, progression free and overall survival. This trial study is based on genetic tests, then therapeutic target drugs are administered according to the genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit from precise treatment which targets particular genetic abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary cancer patients.

The genetic tests are performed for the eligible subjects in this study, then therapeutic target drugs are administered according to the genetic test reports. While the precise treatments, follow-ups are conducted to evaluate the efficacy and safety of the target drugs for the subjects, until the overall survival.

Connect with a study center

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

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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