Treatment of liver cancer using a bioartificial liver device after surgery

A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy

This study tests whether a special liver device can help patients recover better after surgery for liver cancer.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05035108 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, single-arm cohort study involving 10 patients who have undergone extensive hepatectomy for liver cancer. The study will apply a bioartificial liver device 48-72 hours post-surgery to assess its safety and effectiveness. Patients will be monitored in the ICU, with evaluations of liver function, liver volume, and the incidence of liver failure conducted at various intervals following treatment. The goal is to analyze recovery and regeneration of liver function after the intervention.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with liver cancer or benign liver tumors who are undergoing liver resection and have Child A-B liver function.

Not a fit: Patients in the late stages of liver disease or those with severe systemic conditions or infections may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver recovery and reduce the risk of liver failure in patients after extensive liver surgery.

How similar studies have performed: While this approach is innovative, similar studies using bioartificial liver devices have shown promise in improving liver function post-surgery.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection;
2. Liver function Child A-B;
3. There is no contraindication to surgery for cardiopulmonary function;
4. The expected remaining liver volume/standard liver volume is less than 50%;

Exclusion Criteria:

1. 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;
2. PaO2/FiO2 is less than 200 and cannot be corrected;
3. Patients with diffuse intravascular coagulation;
4. Those with active bleeding;
5. Uncontrolled infection;
6. The platelet count is less than 50,000/μL and cannot be corrected;
7. There is no blood vessel available for dialysis treatment;
8. HIV, HDV or HCV positive;
9. Drug abuse within 1 year;
10. Those with severe systemic circulatory failure;
11. Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.;
12. Combined pregnancy;
13. Patients with hepatorenal syndrome;
14. Patients with autoimmune liver disease;
15. Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency);
16. Other conditions that the clinician believes cannot tolerate the treatment.

Where this trial is running

Hangzhou, Zhejiang

• Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Yifan Wang, MD — Sir Run Run Shaw Hospital
• Study coordinator: Xiujun Cai, MD

Conditions Hepatoma Resectable