PDO/PDO-TIL/PDOTS for Drug Screen

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jun 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying new ways to treat liver cancer by using special lab-grown models that mimic how tumors behave in the body. These models, called patient-derived organoids and tissue spheroids, will help researchers test different medications to find the most effective treatments for individual patients. The goal is to better understand why some patients might not respond to certain drugs and to improve treatment options, ultimately enhancing the overall health and recovery of liver cancer patients.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with liver cancer or metastatic liver cancer, meaning the cancer has spread from the liver to other parts of the body. You should also be in relatively good health, with a specific performance status indicating you can carry out daily activities. If you qualify and choose to join, you’ll be contributing to important research that could lead to more personalized and effective treatments for liver cancer. Additionally, participants will need to use effective birth control during the study, especially if they are women of childbearing age.

Gender

ALL

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.