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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: STOMACH NEOPLASM

Treatments: Procedure: surgical resection; Other: neoadjuvant therapy; Other: Adjuvant chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06792149

GC-3D-Bioprinting

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Group A

Description:

gastric cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery

Treatment:

Other: Adjuvant chemotherapy

Procedure: surgical resection

Group B

Description:

gastric cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery

Treatment:

Other: Adjuvant chemotherapy

Other: neoadjuvant therapy

Procedure: surgical resection

Group C

Description:

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.

Treatment:

Procedure: surgical resection