PDO/PDO-TIL/PDOTS for Drug Screen

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer; Metastatic Liver Cancer
• Intervention / Treatment: Other: Drug screen with PDO/PDO-TIL/PDOTS

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Bo Hu, Doctor; Phone Number: +8613701897234; Email: drbohu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Liver cancer or metastatic liver cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Evaluated by researchers based on the RECIST 1.1 standard	1 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: B2022-063R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No