Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: precise medicine.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Biliary Tract Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Genetic precise medicine
During screening stage, all patients should accept next-generation sequencing (NGS) test.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 year]
Secondary outcome measures (6)
- Overall Survival (OS) [Time frame: 2 years]
- Objective response rates (ORR) [Time frame: From treatment initiation to CR or PR, up to 2 years]
- Disease Control Rate (DCR) [Time frame: From treatment initiation to SD, CR or PR, up to 2 years]
- Duration of Response (DOR) [Time frame: From treatment initiation to PD, up to 2 years]
- Adverse Drug Reaction (ADR)/Adverse Event (AE) [Time frame: Through study completion, an average of 2 years.]
- Quality of Life (QoL) after treatment [Time frame: Through study completion, an average of 2 years.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- The subjects participate in any other clinical trial in the meantime.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT05520788 · TJ-IRB20220129