Status:
UNKNOWN
Gastric Cancer Organoids in the Screening of Neoadjuvant Drugs
Lead Sponsor:
Dong Bing Zhao
Conditions:
Gastric Cancer
Organoid
Eligibility:
All Genders
18-80 years
Brief 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. Orga...
Detailed Description
There is an important clinical problem in neoadjuvant chemotherapy, adjuvant chemotherapy and palliative chemotherapy for locally advanced gastric cancer, that is, insufficient effectiveness of chemot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 28 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06196554
Start Date
May 1 2023
End Date
June 28 2024
Last Update
January 9 2024
Active Locations (1)
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1
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, 100021