PDO/PDO-TIL/PDOTS for Drug Screen

NCT05913141 | Recruiting

• 1 other identifier: B2022-063R
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Metastatic Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Evaluated by researchers based on the RECIST 1.1 standard

  1 years

Secondary Outcomes (8)

• Progression free survival (PFS)

  Evaluated by researchers based on the RECIST 1.1 standard

• Relapse-free survival (RFS)

  1 year

• Overall survival (OS)

  1 years

• To the relief time (TOR)

  1 years

• Duration of relief (DOR)

  1 years

Study Arms (1)

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

Interventions

Drug screen with PDO/PDO-TIL/PDOTS OTHER

Drug screen with patient-derived organoids, patient-derived organoids-tumor-infiltrating lymphocyte coculture system, or patient-derived organotypic tissue spheroids.

Patients with PDO/PDO-TIL/PDOTS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver cancer or metastatic liver cancer

You may qualify if:

• ≥18 years old, male or female.
• Liver cancer or metastatic liver cancer diagnosed clinically or pathologically, at least one measurable lesion.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Patient has given written informed consent.
• The function of important organs meets the requirements.
• 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.

You may not qualify if:

• 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).
• 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.
• Have clinical symptoms or diseases that are not well controlled.
• Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization.
• Arterial/venous thrombosis in the first 6 months of randomization.
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

Patients tumor sample and peritumor sample.

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)