NCT04373928

Brief Summary

Pancreatic cancer (PC) is the 4th common cancer in the world and occupied the second place for digestive tumors, of which the incidence has also increased sharply in China. It harbors a particularly poor prognosis due to the late onset of symptoms and the advanced stage that the disease usually reaches before diagnosis. Therefore, searching more sensitive and accurate tumor markers has great value for application. Circulating tumor cell (CTC) is a noninvasive index that could help diagnosis and monitor the load of tumor, having excellent prospect for clinical application. Early in the formation and growth of a primary tumor (breast, colon, lung, or prostate cancer, et al.), CTC are released into blood. The published studies on CTCs have focused on their prognostic significance, utility in real-time monitoring of therapies, resistance targets and understanding the process of metastasis. Our main purpose is to use the platform to identify correlations between CTC counts and PC progression. Chemotherapy plays an important role in the postoperative treatment for PC. However, the efficiency of chemotherapeutic drugs for PC remains relatively limited. Patient-derived xenograft (PDX) preferably reproduce the clinical biological characteristics of PC, leading that we could deeply study the pathogenesis and metastasis of PC. Moreover, using PDX platform defines drug-resistant PC. From the present study, PDX and Mini-PDX platforms maintained architectural characteristics of the original PC specimen after continuous passaging, which could reflect the preclinical medicine study, better serving the clinical chemotherapy and improving the treatment efficiency. Conditional reprogramming (CR) technique adds no virus or cell oncogene to the non-genetic operation, which will not change any gene phenotype during normal growth and continuous passage of the cells in vitro. After a small sample of PC patient is obtained by CR, the project could enlarge the tumor samples from micro-biopsy tissue samples, and provide a basis for the follow-up of tumor drug susceptibility testing. This experiment also uses ctDNA (circulation tomor DNA)technology to detect the genetic information of PC, through which it is expected to improve personalized precision diagnosis and treatment of PC and help to establish a complete database of individual PC PDX. It provides ideal research materials and platform for basic development and translational medicine research of oncology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

November 10, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

7.1 years

First QC Date

November 7, 2019

Last Update Submit

August 31, 2023

Conditions

Pancreatic Cancer

Keywords

PDX,Mini-PDX,ctDNA,Conditional Reprogramming cells

Outcome Measures

Primary Outcomes (1)

  • OS

    Observing and comparing OS (overall survival time) between two groups.

    up to 24 months

Secondary Outcomes (1)

  • DFS

    up to 24 months

Study Arms (2)

Drug guided by Mini-PDX/PDX

EXPERIMENTAL

Procedure: The tumor tissue is used for drug sensitivity test by Mini-PDX, building PC PDX, and acquiring the genetic information by the second genetic sequence or RNA-sequence. PC patients will accept personalized treatment guided by the experimental results of mini-PDX and sequencing.

Procedure: Drug guided by Mini-PDX/PDX

Drug according to guideline

NO INTERVENTION

The drugs (gemcitabine, Nab-paclitaxel, S-1) are used ccording to NCCN pancreatic cancer guideline。

Interventions

Drug guided by Mini-PDX/PDXPROCEDURE

Chemotherapeutic agents guided by Mini-PDX/PDX will be applied to PC patients and the efficiency will be studied.

Also known as: Mini-PDX/PDX
Drug guided by Mini-PDX/PDX

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing radical resection of pancreatic cancer;
  • No serious underlying disease;
  • No preoperative chemotherapy;
  • The diagnosis of pancreatic cancer;
  • No significant heart, lung or renal function;
  • No HIV or syphilis infection;
  • All patients should sign the informed consent.

You may not qualify if:

  • Preoperative general condition was poor, and it was estimated that the operation and postoperative chemotherapy and targeted therapy could not be tolerated;
  • Patients with unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmia, cardiac infarction in the past 6 months, and prolonged QT interval (\>450ms).
  • Patients with other malignancies in the last 5 years.
  • Patients are not subject to follow-up or other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

Related Publications (5)

  • Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.

    PMID: 15317891RESULT

  • Cohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail NY, Picus J, Morse M, Mitchell E, Miller MC, Doyle GV, Tissing H, Terstappen LW, Meropol NJ. Relationship of circulating tumor cells to tumor response, progression-free survival, and overall survival in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Jul 1;26(19):3213-21. doi: 10.1200/JCO.2007.15.8923.

    PMID: 18591556RESULT

  • Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

    PMID: 24553385RESULT

  • Fiebig HH, Maier A, Burger AM. Clonogenic assay with established human tumour xenografts: correlation of in vitro to in vivo activity as a basis for anticancer drug discovery. Eur J Cancer. 2004 Apr;40(6):802-20. doi: 10.1016/j.ejca.2004.01.009.

    PMID: 15120036RESULT

  • Suprynowicz FA, Upadhyay G, Krawczyk E, Kramer SC, Hebert JD, Liu X, Yuan H, Cheluvaraju C, Clapp PW, Boucher RC Jr, Kamonjoh CM, Randell SH, Schlegel R. Conditionally reprogrammed cells represent a stem-like state of adult epithelial cells. Proc Natl Acad Sci U S A. 2012 Dec 4;109(49):20035-40. doi: 10.1073/pnas.1213241109. Epub 2012 Nov 19.

    PMID: 23169653RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jin Gang, M.D.

    Department of general surgery, Changhai Hospital

    STUDY CHAIR

Central Study Contacts

Guo Shiwei, M.D.

CONTACT

18621500666gestwa@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: According to randomized principles, patients with pancreatic cancer will be assigned to intervention group. Collecting the tumor tissue of intervention group and testing the best medicine by Mini PDX, which the person of intervention group receive the best medicine.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending surgeon at the Institute of Pancreatic surgery

Study Record Dates

First Submitted

November 7, 2019

First Posted

May 5, 2020

Study Start

November 10, 2017

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)