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

April 22, 2022 updated by: Shanghai Minimally Invasive Surgery Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sahnghai
      • Shanghai, Sahnghai, China, 200000
        • Shanghai Ruijin Hospttal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced gastric cancer whose tumor is located in the stomach and need neoadjuvant therapy before radical surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: an average of 1 year
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
Time Frame: an average of 1 year
postoperative complication
an average of 1 year
postoperative tumor regression grading
Time Frame: 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.
an average of 1 year
3-year recurrence rate
Time Frame: an average of 3 year
proportion of patients who relapse within 3 years after operation
an average of 3 year
chemotherapy tolerance and adverse reaction rate
Time Frame: an average of 1 year
an average of 1 year
R0 resection rate
Time Frame: an average of 1 year
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Minimally Invasive Surgery Center

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISC-WXXR-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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