The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer
- Conditions
- Advanced Gastric Carcinoma
- Interventions
- Drug: PDO groupDrug: Traditional group
- Registration Number
- NCT05351398
- Lead Sponsor
- Shanghai Minimally Invasive Surgery Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PDO group PDO group 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. Traditional group PDO group 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. Traditional group Traditional group 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. PDO group Traditional group 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate an average of 1 year proportion of patients whose tumor volume reduced to a predetermined value and maintain the minimum time limit.
- Secondary Outcome Measures
Name Time Method postoperative complication an average of 1 year postoperative complication
postoperative tumor regression grading an average of 1 year 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.
3-year recurrence rate an average of 3 year proportion of patients who relapse within 3 years after operation
chemotherapy tolerance and adverse reaction rate an average of 1 year R0 resection rate an average of 1 year
Trial Locations
- Locations (1)
Shanghai Ruijin Hospttal
🇨🇳Shanghai, Sahnghai, China