NCT05520788 Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing
| NCT ID | NCT05520788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2020-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Wanguang Zhang
STUDY CHAIR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT05520788 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05520788 currently recruiting?
Yes, NCT05520788 is actively recruiting participants. Contact the research team at bixiangzhang@hust.edu.cn for enrollment information.
Where is the NCT05520788 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05520788 clinical trial?
NCT05520788 is sponsored by Tongji Hospital. The principal investigator is Wanguang Zhang at Tongji Hospital. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.