PDO/PDO-TIL/PDOTS for Drug Screen

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913141
• Other study ID #: B2022-063R
• Status: Recruiting
• Start date: June 2023
• Est. completion date: June 2026

Study information

• Verified date: June 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This clinical trial aims to use the patient-derived organoid (PDO), Patient-derived organoids-tumor-infiltrating lymphocyte coculture system (PDO-TIL) and patient-derived organotypic tissue spheroids (PDOTS) to simulate the tumor microenvironment in cancer patients. The culture system can be used for pre-clinical validation of drugs and screening of drugs to treat sensitive people and provide individualized treatment for patients with liver cancer. This model is used to explore the molecular mechanism of drug resistance and to find intervention strategies to further improve the response rate of drugs. This study is expected to provide an ideal platform for drug screening and drug resistance research in liver cancer patients, which can replace experimental animal models, and guide personalized medication for liver cancer patients, so as to improve the overall prognosis of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Metastatic Liver Cancer

Intervention

Other:
• Drug screen with PDO/PDO-TIL/PDOTS
Drug screen with patient-derived organoids, patient-derived organoids-tumor-infiltrating lymphocyte coculture system, or patient-derived organotypic tissue spheroids.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Evaluated by researchers based on the RECIST 1.1 standard	1 years
Secondary	Progression free survival (PFS)	1 years	Evaluated by researchers based on the RECIST 1.1 standard
Secondary	Relapse-free survival (RFS)	From the date of enrollment to tumor recurrence or Death	1 year
Secondary	Overall survival (OS)	The date of Death of any causes since the date of enrollment	1 years
Secondary	To the relief time (TOR)	Evaluated by researchers based on the RECIST 1.1 standard	1 years
Secondary	Duration of relief (DOR)	Evaluated by researchers based on the RECIST 1.1 standard	1 years
Secondary	Disease control rate (DCR)	Evaluated by researchers based on the RECIST 1.1 standard	1 years
Secondary	6-month survival rate	Evaluated by researchers based on the RECIST 1.1 standard	6 months
Secondary	12-month survival rate	Evaluated by researchers based on the RECIST 1.1 standard	12 months