Health TrialsbyHealthPanel

PDO/PDO-TIL/PDOTS for Drug Screen

ConditionsLiver CancerMetastatic Liver Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorShanghai Zhongshan Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥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.

Disqualifiers

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.

Trial population

Liver cancer or metastatic liver cancer

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Drug screen with PDO/PDO-TIL/PDOTS

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients with PDO/PDO-TIL/PDOTS1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Evaluated by researchers based on the RECIST 1.1 standard

Time frame
1 years

Secondary outcomes

1

Progression free survival (PFS)

1 years

Time frame
Evaluated by researchers based on the RECIST 1.1 standard
2

Relapse-free survival (RFS)

From the date of enrollment to tumor recurrence or Death

Time frame
1 year
3

Overall survival (OS)

The date of Death of any causes since the date of enrollment

Time frame
1 years
4

To the relief time (TOR)

Evaluated by researchers based on the RECIST 1.1 standard

Time frame
1 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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