Clinical trial · Interventional
Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors
NCT06332716CI-TRIAL-00075461unknownPhase 3ClinicalTrials.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)
Study the correlation between in vitro drug sensitivity screening of digestive tract tumor organoids and their clinical efficacy in anti-tumor treatment, evaluate the use of digestive tract tumor organoid drug sensitivity to predict the therapeutic effect of anti-tumor drugs, and explore new methods for personalized and precise treatment of esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Tumors,3D Organoids,Drug Sensitivity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group based on organoid drug sensitivity testing
- description
- Develop relevant treatment plans through organoid drug sensitivity testing and guide the experimental group in medication use.
- interventionNames
- Other: Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time.
- type
- OTHER
- label
- Historical control group
- description
- Select patients who have previously received full standardized treatment at our center as the control group to evaluate the effectiveness of organoid drug sensitivity screening.
- interventionNames
- Other: Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors confirmed by histopathology/cytology; 1. Esophageal cancer: clinical staging is stage II (cT1-2N1-3M0/cT3-4NOMO) or stage III (cT3-4aN1-3MO); 2. Gastric cancer: Clinical staging is stage II (cT1-2N1-3M0/cT3-4N0MO) or stage III (cT3-4aN1-3MO); 3. Colorectal cancer: clinical staging is stage II (cT1-2N1-3M0/cT3-4N0MO) or stage III (cT3-4aN1-3MO) 4. Gastrointestinal stromal tumors: Primary stromal tumors with locally advanced risk classification (tumor spontaneous rupture; tumor diameter\>10cm; mitotic image\>10/50HPF; tumor diameter\>5cm and mitotic image count\>5/50HPF; 5cm ≤ tumor diameter\>2cm and mitotic image\>5/50HPF non gastric primary stromal tumors; 10cm ≤ tumor diameter\>5cm and mitotic image ≤ 5/50HPF non-gastric primary stromal tumors) or recurrent metastatic/unresectable gastrointestinal stromal tumors. 2. The patient or legal representative voluntarily participates in this study and signs an informed consent form. Exclusion Criteria: 1. Suffering from systemic inflammatory diseases and/or coagulation disorders; 2. There are serious liver and kidney diseases, cardiovascular diseases, respiratory diseases or uncontrolled diabetes; 3. Suffering from other malignant tumors of the system; 4. Patients with mental illness who are unable to cooperate in completing the study; 5. Known allergies to potential chemotherapy drugs or surgical contraindications; 6. Patients whose condition cannot be reversed or in a dying state; 7. Unable to obtain sufficient tumor tissue through biopsy surgery for organoid culture and histological analysis; 8. Pregnancy or lactation, or planning to have a fertility plan within the next 6 months; 9. Poor health status, KPS score\<70 points, or ECOG score ≥ 3 points; 10. Receiving any other anti-cancer drug treatment, biological therapy, radiation therapy, or immunosuppressive therapy within 4 weeks;
References
Publications (0)
Data not yet available
No reference posted for this study.