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

Shanghai Minimally Invasive Surgery Center

Status: Unknown

Conditions: Advanced Gastric Carcinoma

Treatments: Drug: PDO group; Drug: Traditional group

Study type: Observational

Funder types: Other

Identifiers

NCT05351398

MISC-WXXR-002

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

54 participants in 2 patient groups

PDO group

Description:

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.

Treatment:

Drug: PDO group

Drug: Traditional group

Traditional group

Description:

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.

Treatment:

Drug: PDO group

Drug: Traditional group