Actively Recruiting
Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing
Led by Tongji Hospital · Updated on 2025-02-11
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore precise treatments for patients with primary hepatobiliary cancers, including hepatocellular carcinoma and biliary tract cancer. It evaluates the effectiveness and safety of personalized treatment plans based on genetic testing using next-generation sequencing. By identifying specific genetic changes, such as mutations or amplifications, the study seeks to tailor therapies that target these abnormalities to improve patient outcomes. All participants undergo next-generation sequencing testing before treatment to identify relevant genetic mutations. Treatments are then selected according to the genetic test results, using approved targeted drugs. The study focuses on patients with advanced stage IV hepatobiliary cancer receiving palliative care. Follow-up continues to assess progression-free survival, overall survival, and treatment responses over about two years. Participants will be monitored through regular clinical evaluations, including tests to measure tumor progression, response rates, adverse events, and quality of life. The primary outcome is progression-free survival up to two years from treatment start. Secondary measures include overall survival, response duration, safety, and quality of life assessments. The study tracks treatment effectiveness and side effects until the end of the observation period, which may extend to two years or until patient death.
CONDITIONS
Brief Title
Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 65, male or female.
- Radiologically and pathologically confirmed stage IV hepatobiliary cancers.
- Receiving palliative care.
- Next-generation sequencing test shows gene mutation treatable by approved drugs.
- ECOG performance status between 0 and 2.
- Life expectancy of at least 3 months.
- Agree to sign informed consent form.
You will not qualify if you...
- Hepatobiliary cancer patients with stages I to III or suitable for radical resection.
- No gene mutation found by next-generation sequencing or mutation without available treatment.
- ECOG performance status 3 or higher.
- Female patients who are pregnant or not using birth control.
- History or presence of serious cardiovascular or cerebrovascular diseases.
- Abnormal liver or kidney function including jaundice, ascites, or elevated bilirubin.
- Persistent infections above grade 2.
- Major surgery within 4 weeks before screening or not recovered.
- Epilepsy or untreated brain metastases.
- Unhealed wounds, ulcers, fractures, or history of transplantation.
- Severe bleeding events or coagulation disorders.
- Known HIV infection.
- Drug abuse or unstable compliance.
- Unresolved toxicity from previous treatments above grade 1, except certain conditions.
- Participation in another clinical trial during this study.
- Investigator judgment deeming patient unsuitable for enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years from treatment initiation
Participants receive targeted therapy based on genetic test results to treat hepatobiliary cancer.
Duration - Up to 2 years after treatment initiation
Participants are monitored for treatment efficacy and safety, including progression-free survival, overall survival, and adverse events.
Trial Site Locations
Total: 1 location
1
Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
B
Bixiang Zhang, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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