Clinical trial · Observational
Gastric Cancer Organoids in the Screening of Neoadjuvant Drugs
Exploratory Study of Gastric Cancer Organoids in the Screening of Neoadjuvant Chemotherapy and Immunotherapy Drugs
- 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)
Gastric cancer is an important disease burden that threatens human health. Due to the complex biological characteristics of gastric cancer, the research on gastric cancer is still at a low level. Organoid technology is a breakthrough technology in cancer research. Gastric cancer organoid is a good model for gastric cancer research by three-dimensional culture of tumor cells in vitro, which simulates the spatial morphology and structure of tumors in vivo while preserving the biological characteristics of tumor cells. At present, gastric cancer organoid models have shown great advantages in many fields, such as the mechanism of gastric cancer development, tumor drug resistance, large-throughput chemotherapy drug screening, novel therapeutic target searching, and preclinical validation of novel drugs. In the current clinical trial, investigators cultured organoids from gastroscopic biopsy tissue of gastric cancer patients, and compared the organoids with the sampled tumors, including immunohistochemical indicators (Ki67+/CK20+/CDX2+), WES sequencing results. At the same time according to the guidelines. The recommended treatment plan is to compare the organoid model drug screening results with the clinical drug sensitivity.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Organoid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Predictive sensitivity of drug sensitivity
- timeFrame
- At the end of Cycle 2 (each cycle is 21 days); At the end of Cycle 4 (each cycle is 21 days); Ten days after surgery;
- description
- Consistency ratio between organoid drug screening results and actual clinical observation drug sensitivity.
- measure
- Predictive specificity of drug sensitivity
- timeFrame
- At the end of Cycle 2 (each cycle is 21 days); At the end of Cycle 4 (each cycle is 21 days); Ten days after surgery;
- description
- The proportion of inconsistencies between organoid drug screening results and actual clinical observation drug sensitivity.
Secondary outcomes (1)
- measure
- Concordance between organoids and source tumor tissue
- timeFrame
- Organoid models were established and compared after passaging 3-5 generations (Three weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 1: The patients voluntarily participated in this study and signed the informed consent; * 2: 18 to 80 years old. * 3: American Society of Anesthesiologists (ASA) score ≤3 (no risk of anesthesia during surgery). * 4: Patients diagnosed with gastric cancer by pathological examination. * 5: Expected survival is greater than 6 months. * 6: Blood routine: Hb≥70g/L, WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥80×109/L. * 7: Serum ALT and AST≤2×ULN; Serum creatinine≤1.5×ULN. * 8: Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate methods of contraception during the trial. * 9: According to the judgment of the investigator, patients who can comply with the protocol. * 10: Patients with locally advanced gastric cancer requiring neoadjuvant therapy. Exclusion Criteria: * 1: Active or uncontrolled serious infection. * 2: Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment. * 3: A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases. * 4: Chronic renal insufficiency and renal failure. * 5: Patients who have suffered from or combined with other malignant tumors. * 6: Myocardial infarction, severe arrhythmia and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification). * 7: Patients with autoimmune diseases such as systemic lupus erythematosus. * 8: Complications, need to take drugs with serious liver and kidney damage during treatment, such as tuberculosis. * 9: Patients who cannot understand the content of the experiment and cannot cooperate and those who refuse to sign the informed consent. * 10: Those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study. * 11: Combined with neoadjuvant radiotherapy. * 12: Postoperative follow-up was not completed.
References
Publications (0)
Data not yet available