Using gastric cancer organoids to screen neoadjuvant drugs

Exploratory Study of Gastric Cancer Organoids in the Screening of Neoadjuvant Chemotherapy and Immunotherapy Drugs

This study is trying to see if using tiny lab-grown versions of stomach cancer can help doctors choose the best chemotherapy for patients with advanced gastric cancer.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06196554 on ClinicalTrials.gov

What this trial studies

This study focuses on the use of gastric cancer organoids, which are three-dimensional cultures of tumor cells, to improve the effectiveness of neoadjuvant chemotherapy for locally advanced gastric cancer. By comparing organoids derived from biopsy tissues with the actual tumors, researchers aim to better predict patient responses to chemotherapy and adjust treatment strategies accordingly. The study seeks to address the current limitations in predicting chemotherapy effectiveness and aims to enhance personalized treatment approaches for gastric cancer patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 diagnosed with locally advanced gastric cancer who require neoadjuvant therapy.

Not a fit: Patients with active or uncontrolled serious infections or those with decompensated liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment strategies for patients with gastric cancer.

How similar studies have performed: While organoid technology is a promising approach in cancer research, this specific application in gastric cancer treatment is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Beijing

• Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Dongbing Zhao, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Dongbing Zhao, MD

Conditions Gastric Cancer; Organoid; Neoadjuvant Therapy