Gastric Cancer Organoids in the Screening of Neoadjuvant Drugs

NCT06196554 | Unknown FDA Drug

• 1 other identifier: Cancer Institute and Hospital,
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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

Gastric Cancer; Organoid; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (2)

• Predictive sensitivity of drug sensitivity

  Consistency ratio between organoid drug screening results and actual clinical observation drug sensitivity.

  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;

• Predictive specificity of drug sensitivity

  The proportion of inconsistencies between organoid drug screening results and actual clinical observation drug sensitivity.

  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;

Secondary Outcomes (1)

• Concordance between organoids and source tumor tissue

  Organoid models were established and compared after passaging 3-5 generations (Three weeks)

Interventions

Oxaliplatin DRUG

According to the first-line drugs provided by the NCCN guidelines, the concentration of each drug was added to the organoid culture medium after setting 5-6 concentration gradients according to literature reports. Chemo-sensitive and drug-resistant. Construction of gastric cancer organoid T cell co-culture system to screen sensitive immunotherapy drugs.

Also known as: Irinotecan (SN-38), 5-Fluorouracil, Paclitaxel, Pembrolizumab, Nivolumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population was patients with locally advanced gastric cancer receiving neoadjuvant chemotherapy.

You may qualify if:

• : The patients voluntarily participated in this study and signed the informed consent;
• : 18 to 80 years old.
• : American Society of Anesthesiologists (ASA) score ≤3 (no risk of anesthesia during surgery).
• : Patients diagnosed with gastric cancer by pathological examination.
• : Expected survival is greater than 6 months.
• : Blood routine: Hb≥70g/L, WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥80×109/L.
• : Serum ALT and AST≤2×ULN; Serum creatinine≤1.5×ULN.
• : 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.
• : According to the judgment of the investigator, patients who can comply with the protocol.
• : Patients with locally advanced gastric cancer requiring neoadjuvant therapy.

You may not qualify if:

• : Active or uncontrolled serious infection.
• : Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment.
• : A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases.
• : Chronic renal insufficiency and renal failure.
• : Patients who have suffered from or combined with other malignant tumors.
• : Myocardial infarction, severe arrhythmia and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification).
• : Patients with autoimmune diseases such as systemic lupus erythematosus.
• : Complications, need to take drugs with serious liver and kidney damage during treatment, such as tuberculosis.
• : Patients who cannot understand the content of the experiment and cannot cooperate and those who refuse to sign the informed consent.
• : Those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study.
• : Combined with neoadjuvant radiotherapy.
• : Postoperative follow-up was not completed.

Sponsors & Collaborators

• Dong Bing Zhao: lead

Study Sites (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, 100021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Crushed ice was put into the special box for sampling, and several tissue protection media were prepared and placed in the ice box. The tissues were stored in the sample protection media immediately after isolation and transported to the laboratory. Ice PBS was poured into an ordinary petri dish, and the newly obtained gastric cancer tissue of enrolled patients was removed and cleaned in the dish with long tweezers (if the tissue was large, it could be cut into small pieces for easy cleaning) until clean.

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Irinotecan; Fluorouracil; Paclitaxel; pembrolizumab; Nivolumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dongbing Zhao, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongbing Zhao, MD

CONTACT

13071136189; dbzhao@cicams.ac.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 9, 2024
• Study Start: May 1, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: January 9, 2024

Record last verified: 2023-12

Locations

CN (1)