Precision medicine for liver and biliary cancers using genetic testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore precision treatment options for patients with primary hepatobiliary cancers, specifically hepatocellular carcinoma and biliary tract cancer. It evaluates the efficacy and safety of individualized treatment regimens based on next-generation sequencing (NGS) results. Eligible patients will undergo genetic testing to identify specific mutations, amplifications, or translocations, allowing for targeted therapies that align with their genetic profiles. The study will monitor treatment outcomes, including progression-free survival and overall survival, to assess the effectiveness of these personalized approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Zeyang Ding — Tongji Hospital
• Study coordinator: Bixiang Zhang, PhD
• Email: bixiangzhang@hust.edu.cn
• Phone: 86-027-83665293

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.