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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | gastric cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery |
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| Group B | gastric cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical resection | Procedure | Surgical resection will be performed for locoregional lesions . |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients |
| From enrollment to end within 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response of Gastric Cancer Patients to Adjuvant Chemotherapy | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HuaYu Yang, PhD | Contact | 8600-13911800460 | dolphinyahy@163.com | |
| LiWei Du, Master | Contact | 8600-18046606676 | duliwei_liver@pumc.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30344100 | Result | 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. | |
| 38964315 |
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Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.
The IPD data will available after the study is completed
Data can be accessed via e-mail with reasonable requests.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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resected tumor tissue from surgery
| Adjuvant chemotherapy | Other | Regimens of adjuvant chemotherapy are directed by clinical guidance and experience. |
|
| neoadjuvant therapy | Other | Regimens of neoadjuvant chemotherapy are directed by clinicalguidance and experience |
|
| Up to 2 years |
| Result |
| 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |