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New treatment option for Hepatoma Resectable
Official title The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy
ClinicalTrials.gov ID: NCT05035108
What this study is testing
What is hiHep bioartificial liver therapy?
hiHep bioartificial liver therapy is an investigational medicine, being studied as a potential treatment for hepatoma resectable.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- It is a prospective, non-randomized, single-arm cohort study. A total of 10 patients will be included in this study.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection;
- Liver function Child A-B;
- There is no contraindication to surgery for cardiopulmonary function;
- The expected remaining liver volume/standard liver volume is less than 50%;
You likely can't join if
- In the late stage of the disease, patients with frequent symptoms such as cerebral edema accompanied by cerebral herniation and clinical evidence...
- PaO2/FiO2 is less than 200 and cannot be corrected;
- Patients with diffuse intravascular coagulation;
- Those with active bleeding;
- Uncontrolled infection;
- The platelet count is less than 50,000/μL and cannot be corrected;
See the full eligibility criteria
- Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection;
- Liver function Child A-B;
- There is no contraindication to surgery for cardiopulmonary function;
- The expected remaining liver volume/standard liver volume is less than 50%;
- In the late stage of the disease, patients with frequent symptoms such as cerebral edema accompanied by cerebral herniation and clinical evidence indicating intracranial hemorrhage;
- PaO2/FiO2 is less than 200 and cannot be corrected;
- Patients with diffuse intravascular coagulation;
- Those with active bleeding;
- Uncontrolled infection;
- The platelet count is less than 50,000/μL and cannot be corrected;
- There is no blood vessel available for dialysis treatment;
- HIV, HDV or HCV positive;
- Drug abuse within 1 year;
- Those with severe systemic circulatory failure;
- Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.;
- Combined pregnancy;
- Patients with hepatorenal syndrome;
- Patients with autoimmune liver disease;
- Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency);
- Other conditions that the clinician believes cannot tolerate the treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.