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

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

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 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).
5. ECOG performance status 0-2.
6. Life expectancy ≥3 months.
7. Agree to sign informed consent form.

Exclusion Criteria:

1. 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.
2. The result of NGS test show the patient has no gene mutation, or has gene mutation but no medicine.
3. ECOG performance status ≥ 3.
4. Female patients who are pregnant or not using a contraceptive method of birth control.
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 for Adverse Events \[CTC-AE\] v4.0), creatinine ratio \> 3.5g/24 hours, renal failure.
7. Persistent infection \> grade 2 (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTC-AE\] v4.0).
8. Patient has underwent a major operation 4 weeks prior to screening or has not yet recovered 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 past history 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) , present evidence 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 Criteria for Adverse Events \[CTC-AE\] v4.0), except alopecia, anemia or hypothyroidism).
15. Investigator consider that the patient should not be enrolled in this study by careful assessment.
16. The subjects participate in any other clinical trial in the meantime.

Conditions5

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