Prediction of Drug Response in Gastric Cancer Based on 3D Bioprinting

January 19, 2025 updated by: Peking Union Medical College Hospital

Research on the Value of Predicting Drug Efficacy Based on 3D Bioprinting for Constructing in Vitro Gastric Cancer Models

The therapeutic regimens for adjuvant and neoadjuvant chemotherapy in gastric cancer (GC) predominantly hinge on clinical experience. Consequently, there is an imperative need for preclinical models to facilitate the guidance of individualized medicine. The investigators plan to establish three-dimensional (3D) bioprinted GC models derived from surgically resected tumor tissues of GC patients. These in vitro 3D models will be subjected to treatment with the identical chemotherapy drugs administered to the corresponding patients from whom the models are sourced. The sensitivity of the chemotherapy drugs will be assayed within the in vitro models, and the actual response to chemotherapy in patients will be meticulously evaluated. This observational study aims to substantiate the potential utility of 3D bioprinted tumor models in prognosticating the response to chemotherapy in GC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

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 Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Contact:
          • LiLei Mao
        • Contact:
          • WeiMing Kang, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with a clinical and pathological diagnosis of gastric cancer are deemed eligible for this study. Clinical physicians will meticulously record the medical histories, restricting inclusion to patients aged 18 years and above. Exclusion criteria encompass individuals with concomitant malignancies or severe comorbidities. Patients incapable of providing autonomous informed consent are ineligible for participation. All participants will undergo adjuvant or neoadjuvant chemotherapy, followed by surgical resection, as part of the treatment protocol for localized gastric cancer.

Description

Inclusion Criteria:

  • More than 18 years old
  • Patients previously diagnosed with gastric cancer or confirmed by pathology as having gastric cancer postoperatively.
  • Patients who have undergone preoperative imaging examinations, including plain and contrast-enhanced CT scans of the chest, abdomen, and pelvis, as well as gastric MRI for tumor staging, and who are planned for preoperative (neo)adjuvant therapy after multidisciplinary team (MDT) discussion; patients with advanced gastric cancer who are confirmed by postoperative pathology to require (neo)adjuvant therapy.
  • The patient or their family members are able to comprehend the research protocol and are willing to participate in this study, providing written informed consent.

Exclusion Criteria:

  • History of other malignancies or serious medical conditions
  • Inability to provide independent informed consent

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
Group A
gastric cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery
Procedure: surgical resection
Surgical resection will be performed for locoregional lesions .
Other: Adjuvant chemotherapy
Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.
Group B
gastric cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery
Procedure: surgical resection
Surgical resection will be performed for locoregional lesions .
Other: Adjuvant chemotherapy
Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.
Other: neoadjuvant therapy
Regimens of neoadjuvant chemotherapy are directed by clinicalguidance and experience
Group C
Gastric cancer patients who are not scheduled to undergo neoadjuvant chemotherapy prior to surgical intervention and who will not receive adjuvant chemotherapy during the postoperative follow-up period.
Procedure: surgical resection
Surgical resection will be performed for locoregional lesions .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients
Time Frame: From enrollment to end within 2 weeks
  1. Response of 3D tumor models to chemotherapy drugs identical to those administered to corresponding patients: Researchers will establish and culture 3D printed gastric cancer models and treat them with the same chemotherapy drugs used for the corresponding patients. Following treatment, the viability of the 3D tumor models will be observed, and the IC50 of each drug will be calculated. The correlation between the sensitivity of the 3D models and the patients' responses will be analyzed.
  2. Response of Gastric Cancer Patients to Neoadjuvant Chemotherapy: For patients who undergo neoadjuvant chemotherapy prior to surgery, the response to such treatment will be assessed based on clinical imaging results, the Mandard-TRG criteria, and the RECIST score.
From enrollment to end within 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response of Gastric Cancer Patients to Adjuvant Chemotherapy
Time Frame: Up to 2 years
The response to adjuvant chemotherapy will be assessed based on disease-free survival (DFS) or Overall Survival (OS). Regular follow-ups will be conducted. DFS is defined as the interval between the date of surgery and the date of the last follow-up or the date of recurrence/progression.Overall survival (OS) is delineated as the temporal span from the date of surgery to the date of death or the date of the last follow-up, whichever occurs first.
Up to 2 years

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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 (Actual)

October 1, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 19, 2025

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC-3D-Bioprinting

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.

IPD Sharing Time Frame

The IPD data will available after the study is completed

IPD Sharing Access Criteria

Data can be accessed via e-mail with reasonable requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on STOMACH NEOPLASM

Clinical Trials on surgical resection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe