Actively Recruiting

Age: 18Years +
All Genders
ID06792149

Prediction of Drug Response in Gastric Cancer Using 3D Bioprinted In Vitro Tumor Models

Led by Peking Union Medical College Hospital · Updated on 2025-01-24

60

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying gastric cancer, focusing on how well chemotherapy works for individual patients through a new approach. They are developing three-dimensional bioprinted gastric cancer models from tumor tissues taken during surgery. These lab-grown models will be treated with the same chemotherapy drugs as the patients receive to see if the models can predict how patients respond to treatment. This observational study aims to evaluate whether these 3D tumor models can help forecast chemotherapy effectiveness in gastric cancer. The study involves patients with gastric cancer at different stages: those with resectable stage II/III who will get chemotherapy after surgery, those with locally advanced cancer who will receive chemotherapy before and after surgery, and patients not expected to have chemotherapy before or after surgery. Surgical removal of the tumor is performed, and chemotherapy regimens are guided by clinical experience. The in vitro 3D tumor models will be tested with chemotherapy drugs matching those given to the corresponding patients. Participants will undergo tumor tissue collection during surgery for making the 3D models. Researchers will then compare the drug sensitivity results from these models with the actual clinical response of the patients to chemotherapy over up to two years. The primary outcome is to assess the correlation between drug sensitivity in the lab models and patient response within two weeks from enrollment. Secondary outcomes include monitoring patient responses to adjuvant chemotherapy for up to two years. Patients and their families will provide informed consent and participate in follow-up evaluations as part of this observational study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • More than 18 years old
  • Diagnosed with gastric cancer or confirmed by postoperative pathology
  • Underwent preoperative imaging including CT scans and gastric MRI for tumor staging
  • Planned for preoperative (neo)adjuvant therapy after multidisciplinary team discussion or confirmed to need such therapy by postoperative pathology
  • Able to understand the study and provide written informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 2 weeks

Participants undergo surgical resection of locoregional gastric cancer lesions followed by immediate post-operative care.

Approximately 1 to 2 visits around surgery

Treatment

Duration - Varies by participant, up to 2 years for adjuvant chemotherapy

Participants receive neoadjuvant chemotherapy before surgery and/or adjuvant chemotherapy after surgery as directed by clinical guidance and experience, depending on their assigned treatment group.

Visits depend on chemotherapy schedule, typically multiple visits over treatment period

Post-operative Follow-up

Duration - Up to 2 years

Participants are observed and evaluated during the post-operative follow-up period without receiving additional chemotherapy if not scheduled.

Follow-up visits according to clinical care schedule

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

H

HuaYu Yang, PhD

L

LiWei Du, Master

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

A Comprehensive Human Gastric Cancer Organoid Biobank Captures Tumor Subtype Heterogeneity and Enables Therapeutic Screening.

Helen H N Yan, Hoi Cheong Siu, Simon Law...

https://pubmed.ncbi.nlm.nih.gov/30344100