Testing drug sensitivity in organoids for treating gastrointestinal tumors
Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors
This study is testing if drug sensitivity tests on mini-tumors grown in the lab can help predict which treatments will work best for patients with different types of gastrointestinal cancers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06332716 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the relationship between drug sensitivity testing of organoids derived from gastrointestinal tumors and the effectiveness of anti-tumor treatments. It aims to evaluate how well these organoid tests can predict the therapeutic outcomes for patients with esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors. The study will involve a single-arm, multicenter, open-label approach, enrolling approximately 68 patients across multiple research centers. Participants will undergo drug sensitivity testing based on established clinical guidelines and expert consensus.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with confirmed stage II or III gastrointestinal tumors.
Not a fit: Patients with early-stage gastrointestinal tumors or those with non-cancerous conditions will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with gastrointestinal tumors.
How similar studies have performed: Other studies have shown promise in using organoid models for drug sensitivity testing, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Xi'an, Shaanxi
- XijingH — Xi'an, Shaanxi, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.