PDO/PDO-TIL/PDOTS for Drug Screen

Last updated: June 13, 2023
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Metastases

Metastatic Cancer

Digestive System Neoplasms

Treatment

Drug screen with PDO/PDO-TIL/PDOTS

Clinical Study ID

NCT05913141
B2022-063R
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥18 years old, male or female.
  2. Liver cancer or metastatic liver cancer diagnosed clinically or pathologically, atleast 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 amedically-accepted contraceptive (such as an intrauterine device, contraceptive orcondom) during the study period and within 3 months after the end of the studytreatment period.

Exclusion

Exclusion Criteria:

  1. The patient has any active autoimmune disease or a history of autoimmune disease (suchas the following, but not limited to autoimmune hepatitis, interstitial pneumonia,uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroidHyperfunction; patients with vitiligo; complete remission of asthma in childhood, canbe included without any intervention after adulthood; asthma patients who requirebronchodilators for medical intervention cannot be included).
  2. The patient is using immunosuppressive agents or systemic hormonal therapy to achieveimmunosuppressive purposes (agents amount > 10 mg/day of prednisone or othertherapeutic 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 tendencywithin 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 theresults of the study or lead to the termination of the study, such as alcohol abuse,drug abuse, other serious diseases (including mental illness) requiring combinedtreatment, and serious laboratory abnormalities.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Drug screen with PDO/PDO-TIL/PDOTS
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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