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

NCT ID: NCT06792149

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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STOMACH NEOPLASM

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group A

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

surgical resection

Intervention Type PROCEDURE

Surgical resection will be performed for locoregional lesions .

Adjuvant chemotherapy

Intervention Type OTHER

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

surgical resection

Intervention Type PROCEDURE

Surgical resection will be performed for locoregional lesions .

Adjuvant chemotherapy

Intervention Type OTHER

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

neoadjuvant therapy

Intervention Type OTHER

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.

surgical resection

Intervention Type PROCEDURE

Surgical resection will be performed for locoregional lesions .

Interventions

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surgical resection

Surgical resection will be performed for locoregional lesions .

Intervention Type PROCEDURE

Adjuvant chemotherapy

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

Intervention Type OTHER

neoadjuvant therapy

Regimens of neoadjuvant chemotherapy are directed by clinicalguidance and experience

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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HuaYu Yang, PhD

Role: CONTACT

8600-13911800460

LiWei Du, Master

Role: CONTACT

8600-18046606676

Facility Contacts

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HuaYu Yang, PhD

Role: primary

8600-13911800460

LiWei Du, Master

Role: backup

8600-18046606676

References

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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.

Reference Type BACKGROUND
PMID: 30344100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38964315 (View on PubMed)

Other Identifiers

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GC-3D-Bioprinting

Identifier Type: -

Identifier Source: org_study_id

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