Refractory TumorsODSGT-RefractoNCT07906301
Organoid Drug Sensitivity-Guided Therapy for Refractory Tumors
A study testing Organoid drug sensitivity-guided treatment in people with Refractory Tumors and Organoid, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This multicenter study will evaluate whether patient-derived tumor organoid drug sensitivity testing can help guide treatment selection for adults with refractory, unresectable, or metastatic tumors after standard treatment options have been exhausted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Tumors, Organoid
- What is being tested?
- Organoid drug sensitivity-guided treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older; any sex.
- Unresectable or metastatic disease with measurable lesions according to RECIST version 1.1; any number of prior lines of therapy.
- Ability to obtain sufficient fresh tumor tissue or malignant effusion for organoid establishment before treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Estimated life expectancy of at least 6 months.
- Willingness to participate, ability to comply with follow-up, and signed informed consent.
Who cannot join
- Pregnant or breastfeeding women.
- Clinically significant active cardiac disease within the past 12 months, including congestive heart failure, symptomatic coronary artery disease, arrhythmia, or myocardial infarction.
- Another malignancy within the past 5 years, except cured skin cancer.
- Uncontrolled active bacterial, viral, fungal, mycobacterial, parasitic, or other infection within 4 weeks before enrollment, or a major systemic infection requiring intravenous antibiotics or hospitalization; tumor fever is excluded from this criterion.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality
Haitao Wang, Ph.D, +86-022-88321190, wanght@tmu.edu.cn
Lili Wang, Ph.D, +86-022-88321185
About this study
Official title: A Multicenter, Multi-Arm, Exploratory Platform Clinical Study on the Therapeutic Efficacy of Organoid Drug Sensitivity-Guided Treatment in Patients With Refractory Tumors
This multicenter study will evaluate whether patient-derived tumor organoid drug sensitivity testing can help guide treatment selection for adults with refractory, unresectable, or metastatic tumors after standard treatment options have been exhausted. Fresh tumor tissue or malignant effusion will be collected when clinically obtained, and patient-derived organoids (PDOs) will be established and tested against clinically available drugs. Participants with successful organoid establishment and drug sensitivity results will receive treatment selected with reference to the test results and multidisciplinary clinical judgment. Tumor response will be assessed using RECIST version 1.1, with follow-up for progression, survival, and safety. The study plans nine tumor-specific cohorts.
Read the detailed description
The study is designed to assess the clinical utility of PDO drug sensitivity testing in treatment selection for patients with refractory tumors. After consent and eligibility confirmation, fresh tumor tissue from biopsy or malignant effusion remaining after routine diagnostic needs will be used to establish PDOs. Organoids will undergo dose-response testing with marketed drugs used in clinical practice. Treatment decisions will be informed by the organoid sensitivity results and made by the treating clinicians; the protocol states that the drugs are guideline-recommended or may be considered after multidisciplinary discussion and that dosing will follow approved labeling. Participants will undergo routine imaging assessments and safety monitoring. If organoid culture fails or testing takes longer than 28 days, the participant is defined in the protocol as a removal/exclusion from subsequent study observation. The protocol describes nine tumor cohorts: non-small cell lung cancer, small cell lung cancer, prostate cancer, retroperitoneal leiomyosarcoma, colorectal cancer, gastric cancer, pancreatic cancer, bladder cancer, and non-clear cell renal cell carcinoma.
- Conditions
- Refractory Tumors, Organoid
- Being tested
- Organoid drug sensitivity-guided treatment
- Keywords
- Organoid, Refractory tumors, Precision treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoid drug sensitivity-guided treatmentDrug
Fresh tumor tissue or malignant effusion is collected for patient-derived organoid (PDO) culture. Drug sensitivity testing is performed on successfully established PDOs. The treatment regimen is then selected by investigators based on the drug sensitivity results, using approved agents within label indications or via MDT discussion. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience.
| Study group | Role | What they receive |
|---|---|---|
| Non-Small Cell Lung Cancer- Organoid-Guided Therapy | Experimental | Patients with refractory non-small cell lung cancer receive a treatment regimen selected based on patient-derived organoid (PDO) drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. Receives: Drug: Organoid drug sensitivity-guided treatment |
| Small cell lung cancer | Experimental | Patients with refractory small cell lung cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion Receives: Drug: Organoid drug sensitivity-guided treatment |
| Prostate Cancer - Organoid-Guided Therapy | Experimental | Patients with refractory prostate cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion Receives: Drug: Organoid drug sensitivity-guided treatment |
| Retroperitoneal Leiomyosarcoma - Organoid-Guided Therapy | Experimental | Patients with refractory retroperitoneal leiomyosarcoma receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. Receives: Drug: Organoid drug sensitivity-guided treatment |
| Colorectal Cancer - Organoid-Guided Therapy | Experimental | Patients with refractory colorectal cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. Receives: Drug: Organoid drug sensitivity-guided treatment |
| Gastric Cancer - Organoid-Guided Therapy | Experimental | Patients with refractory gastric cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. Receives: Drug: Organoid drug sensitivity-guided treatment |
| Pancreatic Cancer - Organoid-Guided Therapy | Experimental | Patients with refractory pancreatic cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. Receives: Drug: Organoid drug sensitivity-guided treatment |
| Bladder Cancer - Organoid-Guided Therap | Experimental | Patients with refractory bladder cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. Receives: Drug: Organoid drug sensitivity-guided treatment |
| Non-Clear Cell Renal Cell Carcinoma - Organoid-Guided Therapy | Experimental | Patients with refractory non-clear cell renal cell carcinoma receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. Receives: Drug: Organoid drug sensitivity-guided treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of evaluable participants with complete response (CR) or partial response (PR) assessed by RECIST 1.1. ORR = (CR + PR) / total evaluable participants × 100%, with 95% confidence interval.
Measured: From first dose until disease progression or death (up to 24 months)
Secondary outcomes (1)
Sensitivity, Specificity, and Accuracy of Organoid Drug Sensitivity Model in Predicting Clinical Response
Concordance between patient-derived organoid (PDO) drug sensitivity results and actual clinical response. Sensitivity = TP / (TP + FN); Specificity = TN / (TN + FP); Accuracy = (TP + TN) / (TP + TN + FP + FN). TP = true positive; TN = true negative; FN = false negative; FP = false positive. 95% confidence intervals will be calculated.
Measured: From first dose until disease progression or death (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory TumorsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- North China University of Science and Technology, The First Hospital of Hebei Medical University, The Second Hospital of Hebei Medical University, Shijiazhuang People Hospital, Second Hospital of Shanxi Medical University, Shanxi Province Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Haitao Wang, Ph.D, Study chair, Tianjin Medical University Second HospitalLili Wang, Ph.D, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906301
- Sponsor's protocol ID
- PRECISE-Organoid
- Acronym
- ODSGT-Refracto
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol does not include a pre-specified plan or dedicated funding for sharing individual participant data with external researchers. Data will be maintained by the sponsor and participating sites in accordance with the approved informed consent and local regulatory requirements. This statement may be updated if a data sharing plan is established at a later stage.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multi-Arm, Exploratory Platform Clinical Study on the Therapeutic Efficacy of Organoid Drug Sensitivity-Guided Treatment in Patients With Refractory Tumors
- ClinicalTrials.gov ID
- NCT07906301
- Acronym / sponsor ID
- ODSGT-Refracto / PRECISE-Organoid
- Conditions
- Refractory Tumors, Organoid
- Keywords
- Organoid, Refractory tumors, Precision treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Collaborators
- North China University of Science and Technology, The First Hospital of Hebei Medical University, The Second Hospital of Hebei Medical University, Shijiazhuang People Hospital, Second Hospital of Shanxi Medical University, Shanxi Province Cancer Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 30 Oct 2026 (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 multicenter study will evaluate whether patient-derived tumor organoid drug sensitivity testing can help guide treatment selection for adults with refractory, unresectable, or metastatic tumors after standard treatment options have been exhausted. Fresh tumor tissue or malignant effusion will be collected when clinically obtained, and patient-derived organoids (PDOs) will be established and tested against clinically available drugs. Participants with successful organoid establishment and drug sensitivity results will receive treatment selected with reference to the test results and multidisciplinary clinical judgment. Tumor response will be assessed using RECIST version 1.1, with follow-up for progression, survival, and safety. The study plans nine tumor-specific cohorts.
Detailed description
The study is designed to assess the clinical utility of PDO drug sensitivity testing in treatment selection for patients with refractory tumors. After consent and eligibility confirmation, fresh tumor tissue from biopsy or malignant effusion remaining after routine diagnostic needs will be used to establish PDOs. Organoids will undergo dose-response testing with marketed drugs used in clinical practice. Treatment decisions will be informed by the organoid sensitivity results and made by the treating clinicians; the protocol states that the drugs are guideline-recommended or may be considered after multidisciplinary discussion and that dosing will follow approved labeling. Participants will undergo routine imaging assessments and safety monitoring. If organoid culture fails or testing takes longer than 28 days, the participant is defined in the protocol as a removal/exclusion from subsequent study observation. The protocol describes nine tumor cohorts: non-small cell lung cancer, small cell lung cancer, prostate cancer, retroperitoneal leiomyosarcoma, colorectal cancer, gastric cancer, pancreatic cancer, bladder cancer, and non-clear cell renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Non-Small Cell Lung Cancer- Organoid-Guided Therapy | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory non-small cell lung cancer receive a treatment regimen selected based on patient-derived organoid (PDO) drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. |
| Small cell lung cancer | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory small cell lung cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion |
| Prostate Cancer - Organoid-Guided Therapy | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory prostate cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion |
| Retroperitoneal Leiomyosarcoma - Organoid-Guided Therapy | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory retroperitoneal leiomyosarcoma receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. |
| Colorectal Cancer - Organoid-Guided Therapy | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory colorectal cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. |
| Gastric Cancer - Organoid-Guided Therapy | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory gastric cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. |
| Pancreatic Cancer - Organoid-Guided Therapy | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory pancreatic cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. |
| Bladder Cancer - Organoid-Guided Therap | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory bladder cancer receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. |
| Non-Clear Cell Renal Cell Carcinoma - Organoid-Guided Therapy | Experimental | Drug: Organoid drug sensitivity-guided treatmentPatients with refractory non-clear cell renal cell carcinoma receive a treatment regimen selected based on PDO drug sensitivity results. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience and/or MDT discussion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older; any sex.
- Unresectable or metastatic disease with measurable lesions according to RECIST version 1.1; any number of prior lines of therapy.
- Ability to obtain sufficient fresh tumor tissue or malignant effusion for organoid establishment before treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Estimated life expectancy of at least 6 months.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women.
- Clinically significant active cardiac disease within the past 12 months, including congestive heart failure, symptomatic coronary artery disease, arrhythmia, or myocardial infarction.
- Another malignancy within the past 5 years, except cured skin cancer.
- Uncontrolled active bacterial, viral, fungal, mycobacterial, parasitic, or other infection within 4 weeks before enrollment, or a major systemic infection requiring intravenous antibiotics or hospitalization; tumor fever is excluded from this criterion.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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 |
|---|---|---|
| Organoid drug sensitivity-guided treatmentFresh tumor tissue or malignant effusion is collected for patient-derived organoid (PDO) culture. Drug sensitivity testing is performed on successfully established PDOs. The treatment regimen is then selected by investigators based on the drug sensitivity results, using approved agents within label indications or via MDT discussion. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience. | Drug | Bladder Cancer - Organoid-Guided Therap, Colorectal Cancer - Organoid-Guided Therapy, Gastric Cancer - Organoid-Guided Therapy, Non-Clear Cell Renal Cell Carcinoma - Organoid-Guided Therapy, Non-Small Cell Lung Cancer- Organoid-Guided Therapy, Pancreatic Cancer - Organoid-Guided Therapy, Prostate Cancer - Organoid-Guided Therapy, Retroperitoneal Leiomyosarcoma - Organoid-Guided Therapy, Small cell lung cancer |
Primary outcome
Objective Response Rate (ORR)
Time frame: From first dose until disease progression or death (up to 24 months)
Percentage of evaluable participants with complete response (CR) or partial response (PR) assessed by RECIST 1.1. ORR = (CR + PR) / total evaluable participants × 100%, with 95% confidence interval.
1 secondary outcome
Sensitivity, Specificity, and Accuracy of Organoid Drug Sensitivity Model in Predicting Clinical Response
Time frame: From first dose until disease progression or death (up to 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. The study protocol does not include a pre-specified plan or dedicated funding for sharing individual participant data with external researchers. Data will be maintained by the sponsor and participating sites in accordance with the approved informed consent and local regulatory requirements. This statement may be updated if a data sharing plan is established at a later stage.
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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.
Haitao Wang, Ph.D study chair
Tianjin Medical University Second Hospital
Lili Wang, Ph.D principal investigator
Tianjin Medical University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organoid drug sensitivity-guided treatment in people with Refractory Tumors and Organoid, run by Tianjin Medical University Second 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 5 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haitao Wang, Ph.D (+86-022-88321190, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From first dose until disease progression or death (up to 24 months)). 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 30 Oct 2026.