Actively Recruiting

Age: 18Years - 90Years
All Genders
NCT05913141

PDO/PDO-TIL/PDOTS for Drug Screen

Led by Shanghai Zhongshan Hospital · Updated on 2023-06-22

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

PDO/PDO-TIL/PDOTS for Drug Screen

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older, male or female
  • Diagnosed with liver cancer or metastatic liver cancer with at least one measurable lesion
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Provided written informed consent
  • Important organ functions are adequate
  • Use medically accepted contraception during the study and for 3 months after if of childbearing potential
Not Eligible

You will not qualify if you...

  • Active or history of autoimmune disease (including autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; vitiligo; asthma requiring intervention)
  • Using immunosuppressive agents or systemic hormonal therapy above 10 mg/day prednisone equivalent within 2 weeks before enrollment
  • Uncontrolled clinical symptoms or diseases
  • Significant bleeding symptoms or bleeding tendency within 3 months before randomization
  • Arterial or venous thrombosis within 6 months before randomization
  • Other factors affecting study results or requiring study termination such as alcohol or drug abuse, serious diseases including mental illness, or serious lab abnormalities

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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