PDO/PDO-TIL/PDOTS for Drug Screen

Recruiting

• Conditions: Metastatic Liver Cancer; Liver Cancer
• Interventions: Other: Drug screen with PDO/PDO-TIL/PDOTS

• Registration Number: NCT05913141
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PDO/PDO-TIL/PDOTS	Drug screen with PDO/PDO-TIL/PDOTS	Patients whose tumors were established into patient-derived organoids, patient-derived organoids-tumor-infiltrating lymphocyte coculture systems, or patient-derived organotypic tissue spheroids, and screened for drug-sensitive.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	1 years	Evaluated by researchers based on the RECIST 1.1 standard

Secondary Outcome Measures

Name	Time	Method
To the relief time (TOR)	1 years	Evaluated by researchers based on the RECIST 1.1 standard
12-month survival rate	12 months	Evaluated by researchers based on the RECIST 1.1 standard
Progression free survival (PFS)	Evaluated by researchers based on the RECIST 1.1 standard	1 years
Overall survival (OS)	1 years	The date of Death of any causes since the date of enrollment
Relapse-free survival (RFS)	1 year	From the date of enrollment to tumor recurrence or Death
Duration of relief (DOR)	1 years	Evaluated by researchers based on the RECIST 1.1 standard
Disease control rate (DCR)	1 years	Evaluated by researchers based on the RECIST 1.1 standard
6-month survival rate	6 months	Evaluated by researchers based on the RECIST 1.1 standard

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China