NCT06246630

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Apr 2024Jun 2026

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 3, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Expected
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

January 30, 2024

Last Update Submit

May 14, 2024

Conditions

Advanced Pancreatic Neuroendocrine Tumor

Keywords

p-NETorganoidchemotherapytarget therapy

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.

    1-2 years

Secondary Outcomes (4)

  • Progressive free survival

    1-2 years

  • Overall survival time

    2 years

  • The successful establishment rate of organoids

    1-2 years

  • Concordance between drug sensitivity test results and patients' treatment response

    1-2 years

Study Arms (1)

Organoid-Guided therapy

EXPERIMENTAL

All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.

Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

Interventions

Chemotherapy and targeted-therapy guided by organoid drug sensitivity testOTHER

this study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment, and the study aims to evaluate the clinical effectiveness of the drug and its consistency with in vitro organoid drug sensitivity.

Organoid-Guided therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 and ≤ 75 years old.
  • Histologically or cytologically confirmed locally advanced/metastatic Pancreatic Neuroendocrine Tumor
  • Surgery was considered impossible or can not receive the radical purpose.
  • Able to provide fresh tumor tissue specimens for organoid culture, including: tumor biopsy tissues, tumor surgical specimens, etcy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
  • Expected survival time≥ six months.
  • Patient have been informed and consented, compliance and geographic proximity to ensure adequate follow-up

You may not qualify if:

  • Other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin.
  • History of severe cardiovascular events and myocardial Infarction within twelve months before the study.
  • Patients with psychiatric disorders or with psychotropic substance abuse and inability to abstain.
  • Pregnant or breastfeeding women.
  • According to researcher's consideration, patients with other serious systemic diseases or other conditions that are not suitable for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (13)

  • 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

    BACKGROUND

  • Ribeiro-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: 31842488BACKGROUND

  • Hidalgo 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: 25185190BACKGROUND

  • Li 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: 30726695BACKGROUND

  • Vlachogiannis 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: 29472484BACKGROUND

  • 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: 30344100BACKGROUND

  • Sharick JT, Walsh CM, Sprackling CM, Pasch CA, Pham DL, Esbona K, Choudhary A, Garcia-Valera R, Burkard ME, McGregor SM, Matkowskyj KA, Parikh AA, Meszoely IM, Kelley MC, Tsai S, Deming DA, Skala MC. Metabolic Heterogeneity in Patient Tumor-Derived Organoids by Primary Site and Drug Treatment. Front Oncol. 2020 May 15;10:553. doi: 10.3389/fonc.2020.00553. eCollection 2020.

    PMID: 32500020BACKGROUND

  • Kopper O, de Witte CJ, Lohmussaar K, Valle-Inclan JE, Hami N, Kester L, Balgobind AV, Korving J, Proost N, Begthel H, van Wijk LM, Revilla SA, Theeuwsen R, van de Ven M, van Roosmalen MJ, Ponsioen B, Ho VWH, Neel BG, Bosse T, Gaarenstroom KN, Vrieling H, Vreeswijk MPG, van Diest PJ, Witteveen PO, Jonges T, Bos JL, van Oudenaarden A, Zweemer RP, Snippert HJG, Kloosterman WP, Clevers H. An organoid platform for ovarian cancer captures intra- and interpatient heterogeneity. Nat Med. 2019 May;25(5):838-849. doi: 10.1038/s41591-019-0422-6. Epub 2019 Apr 22.

    PMID: 31011202BACKGROUND

  • Shi X, Li Y, Yuan Q, Tang S, Guo S, Zhang Y, He J, Zhang X, Han M, Liu Z, Zhu Y, Gao S, Wang H, Xu X, Zheng K, Jing W, Chen L, Wang Y, Jin G, Gao D. Integrated profiling of human pancreatic cancer organoids reveals chromatin accessibility features associated with drug sensitivity. Nat Commun. 2022 Apr 21;13(1):2169. doi: 10.1038/s41467-022-29857-6.

    PMID: 35449156BACKGROUND

  • Dijkstra KK, van den Berg JG, Weeber F, van de Haar J, Velds A, Kaing S, Peters DDGC, Eskens FALM, de Groot DA, Tesselaar MET, Voest EE. Patient-Derived Organoid Models of Human Neuroendocrine Carcinoma. Front Endocrinol (Lausanne). 2021 Mar 11;12:627819. doi: 10.3389/fendo.2021.627819. eCollection 2021.

    PMID: 33776923BACKGROUND

  • Kawasaki K, Toshimitsu K, Matano M, Fujita M, Fujii M, Togasaki K, Ebisudani T, Shimokawa M, Takano A, Takahashi S, Ohta Y, Nanki K, Igarashi R, Ishimaru K, Ishida H, Sukawa Y, Sugimoto S, Saito Y, Maejima K, Sasagawa S, Lee H, Kim HG, Ha K, Hamamoto J, Fukunaga K, Maekawa A, Tanabe M, Ishihara S, Hamamoto Y, Yasuda H, Sekine S, Kudo A, Kitagawa Y, Kanai T, Nakagawa H, Sato T. An Organoid Biobank of Neuroendocrine Neoplasms Enables Genotype-Phenotype Mapping. Cell. 2020 Nov 25;183(5):1420-1435.e21. doi: 10.1016/j.cell.2020.10.023. Epub 2020 Nov 6.

    PMID: 33159857BACKGROUND

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jiabin JIN, PhD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiabin JIN, PhD

CONTACT

008618101870031jjb11501@rjh.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician, Pancreatic Disease Center

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

April 3, 2024

Primary Completion

December 25, 2025

Study Completion (Estimated)

June 25, 2026

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)