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

NCT06792149 | Recruiting

• 1 other identifier: GC-3D-Bioprinting
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

STOMACH NEOPLASM

Outcome Measures

Primary Outcomes (1)

• Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients

  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 Outcomes (1)

• Response of Gastric Cancer Patients to Adjuvant Chemotherapy

  Up to 2 years

Study Arms (3)

Group A

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

Procedure: surgical resection; Other: Adjuvant chemotherapy

Group B

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

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

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

Interventions

surgical resection PROCEDURE

Surgical resection will be performed for locoregional lesions .

Group A; Group B; Group C

Adjuvant chemotherapy OTHER

Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.

Group A; Group B

neoadjuvant therapy OTHER

Regimens of neoadjuvant chemotherapy are directed by clinicalguidance and experience

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

• Yan HHN, Siu HC, Law S, Ho SL, Yue SSK, Tsui WY, Chan D, Chan AS, Ma S, Lam KO, Bartfeld S, Man AHY, Lee BCH, Chan ASY, Wong JWH, Cheng PSW, Chan AKW, Zhang J, Shi J, Fan X, Kwong DLW, Mak TW, Yuen ST, Clevers H, Leung SY. A Comprehensive Human Gastric Cancer Organoid Biobank Captures Tumor Subtype Heterogeneity and Enables Therapeutic Screening. Cell Stem Cell. 2018 Dec 6;23(6):882-897.e11. doi: 10.1016/j.stem.2018.09.016. Epub 2018 Oct 18.

  PMID: 30344100 BACKGROUND

• Zhao Y, Li S, Zhu L, Huang M, Xie Y, Song X, Chen Z, Lau HC, Sung JJ, Xu L, Yu J, Li X. Personalized drug screening using patient-derived organoid and its clinical relevance in gastric cancer. Cell Rep Med. 2024 Jul 16;5(7):101627. doi: 10.1016/j.xcrm.2024.101627. Epub 2024 Jul 3.

  PMID: 38964315 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

resected tumor tissue from surgery

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Central Study Contacts

HuaYu Yang, PhD

CONTACT

8600-13911800460; dolphinyahy@163.com

LiWei Du, Master

CONTACT

8600-18046606676; duliwei_liver@pumc.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: October 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 24, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD data will available after the study is completed
• Access Criteria: Data can be accessed via e-mail with reasonable requests.

Locations

CN (1)