Advanced Gastric Carcinoma
Conditions
Keywords
advanced gastric carcinoma, patient-derived organoid, personalized treatment, Neoadjuvant Chemotherapy
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.
Interventions
DRUGPDO 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.
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.
Sponsors
Ruijin Hospital
Shanghai OneTar Biomedicine Co., Ltd.
Shanghai Minimally Invasive Surgery Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactJin Sun, PhD
Outcome results
None listed