An interventional study of Organoid drug sensitivity-guided treatment in Refractory Tumors and Organoid, sponsored by Tianjin Medical University Second Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Tianjin Medical University Second Hospital · Not applicable, Interventional, and Treatment
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 144 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Tianjin Medical University Second Hospital is the lead sponsor of 60 studies on the registry; 36 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Organoid drug sensitivity-guided treatment
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
Drug: Organoid drug sensitivity-guided treatment
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
Drug: Organoid drug sensitivity-guided treatment
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.
Drug: Organoid drug sensitivity-guided treatment
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.
Drug: Organoid drug sensitivity-guided treatment
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.
Drug: Organoid drug sensitivity-guided treatment
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.
Drug: Organoid drug sensitivity-guided treatment
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.
Drug: Organoid drug sensitivity-guided treatment
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.
Drug: Organoid drug sensitivity-guided treatment
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.
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.
Time frame: From first dose until disease progression or death (up to 24 months)
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.
Time frame: From first dose until disease progression or death (up to 24 months)
Plan to share: 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.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Oct 2027, 24 months after the start.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 24 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Tianjin Medical University Second Hospital