Clinical trial · Observational
Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis
Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis
NCT06536725CI-TRIAL-00079437unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Organoid | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Building Organoid-on-chips models | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PCa Patients With Visceral Metastasis
- description
- Prostate cancer patients with visceral metastasis.
- interventionNames
- Other: Building Organoid-on-chips models
Primary outcomes (2)
- measure
- ORR(Objective Response Rate)
- timeFrame
- 18 months
- description
- Selecting ORR as the primary endpoint from clinical efficacy evaluation indicators.Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
- measure
- Clinical Consistency
- timeFrame
- 18 months
- description
- Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically; 2. Age ≥ 18 years old; 3. ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression; 4. Normal liver and kidney function, serum transaminase ALT\<66 U/L, AST\<36 U/L, total bilirubin\<22 umol/L, creatinine\<106 umol/L, urea nitrogen\<6.1 mmol/L; Normal bone marrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3; 5. Can obtain surgical or biopsy samples; 6. Patients voluntarily join this study and sign an informed consent form. Exclusion Criteria: 1. Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc; 2. Patients who are unable to obtain tissue samples; 3. Subjects with active pulmonary tuberculosis (TB); 4. Subjects who are preparing for or have previously undergone tissue/organ transplantation; 5. Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.
References
Publications (0)
Data not yet available
No reference posted for this study.