Using patient-derived models to screen drugs for liver cancer

Patient-derived Organoids, Patient-derived Organoids-tumor-infiltrating Lymphocyte Coculture System, and Patient-derived Organotypic Tissue Spheroids for Drug Screen

This study is testing new ways to use patient samples to find the best drugs for treating liver cancer and to understand why some treatments might not work.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05913141 on ClinicalTrials.gov

What this trial studies

This clinical trial utilizes patient-derived organoids (PDO), tumor-infiltrating lymphocyte coculture systems (PDO-TIL), and organotypic tissue spheroids (PDOTS) to replicate the tumor microenvironment of liver cancer patients. The aim is to validate and screen drugs that can be tailored to individual patients, enhancing treatment efficacy and understanding drug resistance mechanisms. By replacing traditional animal models, this approach seeks to provide a more accurate platform for personalized medicine in liver cancer, ultimately improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with clinically or pathologically diagnosed liver cancer or metastatic liver cancer and at least one measurable lesion.

Not a fit: Patients with active autoimmune diseases or a history of such conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with liver cancer.

How similar studies have performed: While this approach is innovative, similar studies using patient-derived models have shown promise in other cancer types, suggesting potential for success in this context.

Eligibility criteria

Inclusion Criteria:

1. ≥18 years old, male or female.
2. Liver cancer or metastatic liver cancer diagnosed clinically or pathologically, at least one measurable lesion.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
4. Patient has given written informed consent.
5. The function of important organs meets the requirements.
6. Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period.

Exclusion Criteria:

1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included).
2. The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg/day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment.
3. Have clinical symptoms or diseases that are not well controlled.
4. Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization.
5. Arterial/venous thrombosis in the first 6 months of randomization.
6. According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Conditions Liver Cancer; Metastatic Liver Cancer