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Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors

RECRUITINGPhase 3Sponsored by Jianjun Yang,MD
Actively Recruiting
PhasePhase 3
SponsorJianjun Yang,MD
Started2022-08-26
Est. completion2025-12
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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;

Conditions2

CancerGastrointestinal Tumors,3D Organoids,Drug Sensitivity

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