Phase
Condition
Biliary Tract Cancer
Cancer/tumors
Gall Bladder Cancer
Treatment
precise medicine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 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).
ECOG performance status 0-2.
Life expectancy ≥3 months.
Agree to sign informed consent form.
Exclusion
Exclusion Criteria:
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.
The result of NGS test show the patient has no gene mutation, or has gene mutationbut no medicine.
ECOG performance status ≥ 3.
Female patients who are pregnant or not using a contraceptive method of birthcontrol.
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 forAdverse Events [CTC-AE] v4.0), creatinine ratio > 3.5g/24 hours, renal failure.
Persistent infection > grade 2 (according to National Cancer Institute [NCI] CommonTerminology Criteria for Adverse Events [CTC-AE] v4.0).
Patient has underwent a major operation 4 weeks prior to screening or has not yetrecovered 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 pasthistory 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) , presentevidence 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 Criteriafor Adverse Events [CTC-AE] v4.0), except alopecia, anemia or hypothyroidism).
Investigator consider that the patient should not be enrolled in this study bycareful assessment.
The subjects participate in any other clinical trial in the meantime.
Study Design
Study Description
Connect with a study center
Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaActive - Recruiting
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