Clinical trial · Interventional
In Vitro Organoid Drug Sensitivity-Guided Treatment for Advanced Pancreatic Neuroendocrine Tumor
A Prospective, Exploratory Study Evaluating the Effectiveness of Treatment Regimens for Locally Advanced/Metastatic Non-resectable Pancreatic Neuroendocrine Tumor (PNET) Guided by in Vitro Drug Sensitivity Testing of Tumor Organoids
NCT06246630CI-TRIAL-00077171unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to explore whether chemotherapy and targeted-therapy regimens guided by organoid drug sensitivity test can improve the outcomes of non-resectable locally advanced and metastatic Pancreatic neuroendocrine tumors. At the same time, this study will evaluate the successful stablishment rate of organoid from biopsy tissue , and explore the concordance between drug sensitivity test results and patients' treatment response
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Pancreatic Neuroendocrine Tumor | Pancreatic Neuroendocrine Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy and targeted-therapy guided by organoid drug sensitivity test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Organoid-Guided therapy
- description
- All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.
- interventionNames
- Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 1-2 years
- description
- Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.
Secondary outcomes (4)
- measure
- Progressive free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years old. 2. Histologically or cytologically confirmed locally advanced/metastatic Pancreatic Neuroendocrine Tumor 3. Surgery was considered impossible or can not receive the radical purpose. 4. Able to provide fresh tumor tissue specimens for organoid culture, including: tumor biopsy tissues, tumor surgical specimens, etcy. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2. 6. Expected survival time≥ six months. 7. Patient have been informed and consented, compliance and geographic proximity to ensure adequate follow-up Exclusion Criteria: 1. Other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin. 2. History of severe cardiovascular events and myocardial Infarction within twelve months before the study. 3. Patients with psychiatric disorders or with psychotropic substance abuse and inability to abstain. 4. Pregnant or breastfeeding women. 5. According to researcher's consideration, patients with other serious systemic diseases or other conditions that are not suitable for participation.
References
Publications (13)
- BACKGROUND中国临床肿瘤学会神经内分泌肿瘤专家委员会. 中国胃肠胰神经内分泌肿瘤专家共识（2022年版）[J]. 中华肿瘤杂志, 2022, 44(12):1305-1329
- BACKGROUND吴文铭, 陈洁, 白春梅等.中国胰腺神经内分泌肿瘤诊疗指南（2020） [J] . 中华外科杂志, 2021, 59(6) : 401-421
- BACKGROUND王文权, 楼文晖, 刘亮.胰腺神经内分泌肿瘤热点问题的思考[J]. 中华消化外科杂志, 2022, 21(8):1031-1037
- BACKGROUNDRibeiro-Filho AC, Levy D, Ruiz JLM, Mantovani MDC, Bydlowski SP. Traditional and Advanced Cell Cultures in Hematopoietic Stem Cell Studies. Cells. 2019 Dec 12;8(12):1628. doi: 10.3390/cells8121628. PMID 31842488
- BACKGROUNDHidalgo M, Amant F, Biankin AV, Budinska E, Byrne AT, Caldas C, Clarke RB, de Jong S, Jonkers J, Maelandsmo GM, Roman-Roman S, Seoane J, Trusolino L, Villanueva A. Patient-derived xenograft models: an emerging platform for translational cancer research. Cancer Discov. 2014 Sep;4(9):998-1013. doi: 10.1158/2159-8290.CD-14-0001. Epub 2014 Jul 15. PMID 25185190
- BACKGROUNDLi M, Izpisua Belmonte JC. Organoids - Preclinical Models of Human Disease. N Engl J Med. 2019 Feb 7;380(6):569-579. doi: 10.1056/NEJMra1806175. No abstract available. PMID 30726695
- BACKGROUNDVlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774. PMID 29472484
- BACKGROUNDYan 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.