Liver CancerNCT05913141
PDO/PDO-TIL/PDOTS for Drug Screen
An observational study of Liver Cancer and Metastatic Liver Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Cancer, Metastatic Liver Cancer
- What is being tested?
- Drug screen with PDO/PDO-TIL/PDOTS
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2023to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver cancer or metastatic liver cancer
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Bo Hu, Doctor, +8613701897234, drbohu@163.com
About this study
Official title: 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.
- Conditions
- Liver Cancer, Metastatic Liver Cancer
- Being tested
- Drug screen with PDO/PDO-TIL/PDOTS
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug screen with PDO/PDO-TIL/PDOTSOther
Drug screen with patient-derived organoids, patient-derived organoids-tumor-infiltrating lymphocyte coculture system, or patient-derived organotypic tissue spheroids.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Drug screen with PDO/PDO-TIL/PDOTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 1 years
Secondary outcomes (8)
Progression free survival (PFS)
1 years
Measured: Evaluated by researchers based on the RECIST 1.1 standard
Relapse-free survival (RFS)
From the date of enrollment to tumor recurrence or Death
Measured: 1 year
Overall survival (OS)
The date of Death of any causes since the date of enrollment
Measured: 1 years
To the relief time (TOR)
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 1 years
Duration of relief (DOR)
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 1 years
Disease control rate (DCR)
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 1 years
6-month survival rate
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 6 months
12-month survival rate
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Bo, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913141
- Sponsor's protocol ID
- B2022-063R
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-derived Organoids, Patient-derived Organoids-tumor-infiltrating Lymphocyte Coculture System, and Patient-derived Organotypic Tissue Spheroids for Drug Screen
- ClinicalTrials.gov ID
- NCT05913141
- Acronym / sponsor ID
- B2022-063R
- Conditions
- Liver Cancer, Metastatic Liver Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PDO/PDO-TIL/PDOTS | – | Other: Drug screen with PDO/PDO-TIL/PDOTSPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver cancer or metastatic liver cancer
Key inclusion criteria (6 listed)
- ≥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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug screen with PDO/PDO-TIL/PDOTSDrug screen with patient-derived organoids, patient-derived organoids-tumor-infiltrating lymphocyte coculture system, or patient-derived organotypic tissue spheroids. | Other | Patients with PDO/PDO-TIL/PDOTS |
Primary outcome
Objective response rate (ORR)
Time frame: 1 years
Evaluated by researchers based on the RECIST 1.1 standard
8 secondary outcomes
Progression free survival (PFS)
Time frame: Evaluated by researchers based on the RECIST 1.1 standard
Relapse-free survival (RFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 years
To the relief time (TOR)
Time frame: 1 years
Duration of relief (DOR)
Time frame: 1 years
Disease control rate (DCR)
Time frame: 1 years
6-month survival rate
Time frame: 6 months
12-month survival rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Metastatic Liver Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.