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A Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method

A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06100003
Enrollment
104
Registered
2023-10-25
Start date
2023-10-18
Completion date
2025-12-01
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Organoids

Brief summary

The study is a real-world observational clinical study. Patients diagnosed as gastric cancer through histopathology were screened and enrolled. Before anti-tumor treatment, gastroscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in gastric cancer treatment and drug susceptibility outcomes.

Interventions

None listed

Sponsors

Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences
CollaboratorUNKNOWN
Precedo Pharmaceuticals Co. Ltd.
CollaboratorUNKNOWN
Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China
CollaboratorUNKNOWN
Funan Liu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

1. Male or female, aged ≥ 18 and ≤80; 2. Patients with gastric cancer diagnosed by histopathology; 3. Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment; 4. Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained; 5. Patients who sign the informed consent form, and are able to comply with the study period treatment process.

Exclusion criteria

1. Inability to follow the research protocol; 2. Inability to obtain relevant fresh specimens by biopsy/surgery/puncture; 3. Concomitant contraindications to chemotherapy; 4. pregnant or lactating women; 5. Patients deemed inappropriate by investigators.

Design outcomes

Primary

MeasureTime frameDescription
Disease-free survivalFrom date of surgery until the date of first documented recurrence,up to 3 yearsAn Indicator of efficacy of postoperative adjuvant therapy
SensitivityThrough study completion, an average of 1 yearCases in which drug susceptibility results are sensitive to the antineoplastic regimen as a percentage of the cases that are effective in clinical evaluation
SpecificityThrough study completion, an average of 1 yearCases in which drug susceptibility results are resistance to the antineoplastic regimen as a percentage of the cases that are ineffective in clinical evaluation

Countries

China

Contacts

Primary ContactShuhui Song, bachelor
593900927@qq.com83281137

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026