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Advanced Pancreatic Neuroendocrine TumorNCT06246630

In Vitro Organoid Drug Sensitivity-Guided Treatment for Advanced Pancreatic Neuroendocrine Tumor

A study testing Chemotherapy and targeted-therapy guided by organoid drug sensitivity test in people with Advanced Pancreatic Neuroendocrine Tumor, run by Ruijin Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Pancreatic Neuroendocrine Tumor
What is being tested?
Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
3 Apr 2024to 25 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jiabin JIN, PhD contact

008618101870031

jjb11501@rjh.com.cn

China1 site, 1 recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    jiabin JIN, PhD, 008602164370045 ext. 670904, jjb11501@rjh.com.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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

Read the detailed description

Twenty non-resectable locally advanced and metastatic pancreatic neuroendocrine Tumor(p-NET) patients who should receive palliative treatment will be enrolled in this study. Baseline information of the enrolled patients including medical history, physical examination records and clinical examination records will be collected. Tumor material of those patients will be obtained from Pancreatic endoscopic biopsies or surgical resection. Patient-derived organoids (PDOs) will be established and cultured from p-NET tumor specimens. PDOs will then be treated with drugs of the chemotherapeutic and targeted therapeutic regimens for p-NET. Organoid size and growth will be monitored before and after the treatment, and dose-response curves will be generated. As for the assessment of clinical outcomes of patients, treatment responses will be assessed by biomedical imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1). Consistency between treatment responses in PDO models and clinical outcomes of patients will be assessed by correlation analysis.

Being tested
Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Keywords
p-NET, organoid, chemotherapy, target therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06246630
Study groupRoleWhat they receive
Organoid-Guided therapyExperimentalAll patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.
Receives: Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-2 years

Secondary outcomes (4)

  1. Progressive free survival

    The time from initiation of treatment to the occurrence of disease progression or death.

    Measured: 1-2 years

  2. Overall survival time

    The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure.

    Measured: 2 years

  3. The successful establishment rate of organoids

    The rate of organoid successfully cultured in all the samples collected.

    Measured: 1-2 years

  4. Concordance between drug sensitivity test results and patients' treatment response

    To assess the accuracy of drug sensitivity test in both group. The number of patients with correct prediction of treatment response by organoid drug-sensitivity test divided by the number of patients underwent chemotherapy

    Measured: 1-2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start3 Apr 2024
  3. Primary completion25 Dec 2025 (estimated)
  4. Study completion25 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06246630
Sponsor's protocol ID
Ruijin20231007060328844
Status last verified
May 2024
First submitted
30 Jan 2024
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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

  • 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

  • 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.

    PubMed 31842488

  • 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.

    PubMed 25185190

  • 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.

    PubMed 30726695

  • 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.

    PubMed 29472484

  • 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.

    PubMed 30344100

  • 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.

    PubMed 32500020

  • 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.

    PubMed 31011202

  • 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.

    PubMed 35449156

  • 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.

    PubMed 33776923

  • 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.

    PubMed 33159857

Questions about this trial

What is this clinical trial studying?

A study testing Chemotherapy and targeted-therapy guided by organoid drug sensitivity test in people with Advanced Pancreatic Neuroendocrine Tumor, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiabin JIN, PhD (008618101870031, jjb11501@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 1-2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06246630, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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