A Study on the Potential Benefit of Neoadjuvant Therapy for AGC Patients

Early Gastric Cancer Clinical Trial

Official title:

A Prospective Observational Study on the Potential Benefit of Neoadjuvant Therapy for Advanced Gastric Cancer Based on Organoid Drug Susceptibility Screening

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05442138
• Other study ID #: OneTar
• Status: Not yet recruiting
• Start date: August 2022
• Est. completion date: June 2024

Study information

• Verified date: June 2022
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Early gastric cancer（AGC）has no effective characteristic symptoms and signs according to clinical statistics. Neoadjuvant chemotherapy (NAC) significantly reduces the size of AGC tumors so that it has become the recommended treatment for AGC in major guidelines. However, Some patients miss the best time for surgical treatment and may have irreversible chemotherapy side effects due to NAC lacks the guidance of new indicators for precise treatment such as molecular biomarkers. Tumor organoids are highly consistent with the clinical drug sensitivities of patients which could be used as clinical treatment prediction models thus providing guidance for individualized medicine. Therefore, the project is the first to carry out the prospective study by screening the potential benefit populations of NAC based on tumor organoids drug susceptibility experiment. The following hypothesis are put forward：the potential benefit population of NAC screened by tumor organoid drugs susceptibility technology will have better clinical efficacy, better treatment tolerance and higher adverse reaction rate.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: June 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18-75 years old;

2. Qualitative diagnosis: gastroscopic biopsy confirmed adenocarcinoma;

3. Localization diagnosis: the tumor is located in the stomach or gastroesophageal junction;

4. The clinical staging is stage III:

A. Assess tumor stage: T3-4N1-2; B. Excluding distant organ metastasis (M0);

5. Physical condition (ECOG) score = 1 point;

6. Those with effective preoperative neoadjuvant therapy and successful surgery agreed to receive 5 cycles of standard SOX chemotherapy after surgery;

7. Sign the informed consent form and be willing to participate in this project.

Exclusion Criteria:

1. Simultaneous or metachronous multiple primary malignant tumors;

2. Preoperative imaging examination results showed that there was distant metastasis;

3. Preoperative imaging findings:

A. The tumor involving surrounding organs requires combined organ resection; B. Distant organ metastases; C. Those who cannot perform R0 resection;

4. Past history of malignant tumor;

5. Abnormal heart, lung, liver, kidney, hematopoietic function and bone marrow reserve function, unable to tolerate surgical treatment and chemotherapy;

6. Mental illness or other serious cardiovascular disease;

7. Pregnant or lactating women.

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		time before the surgery
Primary	Tumor Regression Grading		time before the surgery