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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
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• 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.

Locations
Other Locations
China
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
RECRUITING
Beijing
Contact Information
Primary
Dongbing Zhao, MD
dbzhao@cicams.ac.cn
13071136189
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2024-06-28
Participants
Target number of participants: 40
Related Therapeutic Areas
Sponsors
Leads: Dong Bing Zhao

This content was sourced from clinicaltrials.gov