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

Sponsor

Shanghai Minimally Invasive Surgery Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05351398

Collaborator

Wuxi Branch of Ruijin Hospital (Other), Shanghai OneTar Biomedicine Co., Ltd. (Other)

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Gastric Carcinoma	Drug: PDO group Drug: Traditional group

Study Design

Study Type:

Observational

Anticipated Enrollment :

54 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: 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. Drug: 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.
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.	Drug: 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. Drug: 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.

Arm

Intervention/Treatment

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.

Drug: PDO group

Drug: 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.

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.

Drug: PDO group

Drug: 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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Ruijin Hospttal	Shanghai	Sahnghai	China	200000

Sponsors and Collaborators

Shanghai Minimally Invasive Surgery Center
Wuxi Branch of Ruijin Hospital
Shanghai OneTar Biomedicine Co., Ltd.

Investigators

Principal Investigator: Jing Sun, PhD, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Minimally Invasive Surgery Center

ClinicalTrials.gov Identifier:

NCT05351398

Other Study ID Numbers:

MISC-WXXR-002

First Posted:

Apr 28, 2022

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shanghai Minimally Invasive Surgery Center

advanced gastric carcinoma

patient-derived organoid

personalized treatment

Neoadjuvant Chemotherapy

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Apr 28, 2022