The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer

Study Overview
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Brief Summary
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Neoadjuvant chemotherapy has become the mainstream recommended treatment for advanced gastric cancer. However, due to the heterogeneity of gastric cancer, part of some patients fail to benefit from the treatment. This project aims to compare the clinical efficacy of individualized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay and traditional regimen, exploring the advantages and disadvantages of these two treatments. And access the safety and clinical value of the personalized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay in advanced gastric cancer.

Official Title
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The Clinical Efficacy of Patient-derived Organoid-based Drug Sensitive Neoadjuvant Chemotherapy Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer: a Prospective Multi-center Randomized Controlled Study

Conditions
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Advanced Gastric Carcinoma

Intervention / Treatment
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* Drug: PDO group
* Drug: Traditional group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 years A biopsy proven histological diagnosis of gastric adenocarcinoma or high-grade intraepithelial neoplasia Tumor located at stomach Chest/abdomen/pelvis CT scans or gastric cancer staging CT scan evaluate the clinical stage of tumor as stage III: A. preoperative staging cT3-4N1-2 B. excluding distant organ metastasis (M0) Eastern Cooperative Oncology Group (ECOG) score ≤1 Willing to participate and informed consent signed Exclusion Criteria: Pregnant or lactating women Synchronous or heterochronic malignant carcinomas History of malignant carcinomas Clinical evidence of metastasis Abnormal heart, lung, liver, kidney, hematopoietic function and bone marrow reserve function, unable to tolerate surgical treatment and chemotherapy Mental illness or other serious cardiovascular disease Emergency procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PDO group<br>Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay. | Drug: PDO group<br>* Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay.<br>Drug: Traditional group<br>* Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen.<br>|
| Traditional group<br>Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen. | Drug: PDO group<br>* Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay.<br>Drug: Traditional group<br>* Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | proportion of patients whose tumor volume reduced to a predetermined value and maintain the minimum time limit. | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complication | postoperative complication | an average of 1 year | 
| postoperative tumor regression grading | grade the pathological response of tumor after neoadjuvant treatment, which is usually classified according to the proportion of fibrosis and residual tumor in tumor tissues. | an average of 1 year | 
| 3-year recurrence rate | proportion of patients who relapse within 3 years after operation | an average of 3 year | 
| chemotherapy tolerance and adverse reaction rate |  | an average of 1 year | 
| R0 resection rate |  | an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced gastric carcinoma, patient-derived organoid, personalized treatment, Neoadjuvant Chemotherapy