ClinicalTrials.gg
Status unknownNCT04373928PPDTPCUpdated Sep 1, 2023

Personalized Precision Diagnosis and Treatment of Pancreatic Cancer

An interventional study of Drug guided by Mini-PDX/PDX in Pancreatic Cancer, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Nov 2017, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Tumor cells are released from the primary tumor and/or metastatic sites into blood. Circulating tumor cells (CTC), as a part of liquid biopsy, is acted as a new method to diagnose cancer. Many studies indicated that CTC counts had a correlation with breast, colon, lung, or prostate cancer development. When individual cells or clusters of cancer cells acquire ability to separate and move away from the primary tumor, migrate through the surrounding tissue, and enter the lymphatic system and/or blood circulation, the metastatic trait of the given tumor become obvious [1-3]. Tumor cells that escape from their primary microenvironment need to avoid anoikis and might be challenged by the host's immunologic defense. Finally, CTC is like a seed that transfer to other organs, contributing to metastasis and recurrence. These CTC could be enriched and detected via different technologies that take advantage of their physical and biologic properties. This study collected CTC by iset platform which checks CTC (pre-operative\postoperative\pre-treatment\during treatment) and observed the association between CTC counts and PC development [4].

Patient-derived xenograft (PDX) was demonstrated to consistently retained tumor morphology and genetic phenotype. Different from traditional cell line xenotransplantation model and genetically engineered mouse model, pancreatic adenocarcinoma specimens were engrafted to immuno-deficient mice. Above all, PDX could keep special functional gene structure and biomarkers in personal case, closer to the individual clinical biological characteristics and providing better prediction effect for drug screening and observation for treatment efficiency.

As some researches discovered, the effective of contrasting drug sensitivity test with clinical drug response is >90% [5]. Now, we build the PDX of PC, checking the genetic information by the second genetic sequence or RNA-sequence. If PDX has similar genetic information to the primary tumor, we will do drug sensitivity test. PC PDX model, whereby we have demonstrated that the early PDX was morphologically similar to the original cancer and retained both inter-patient and intra-patient heterogeneity of the tumor, could provide reference model for personalized treatment of PC.

Above all, the most obvious advantage of PDX is the similarity to primary tumor, so we could check the sensitivity of the same drug. But building PDX will take about 3-4months (including building the model and drug sensitivity test). As a result, we need clinical precision therapeutic plan applying to the developed pancreatic cancer patients. Miniature Patient Derived Xenograft (Mini-PDX), from Shanghai LIDE(lide) Biotech CO(company), was carried out with the OncoVeeTM-Mini PDX product of LIDE Biotech, and followed the instruction from the manufacturer. Tumor samples were harvested, and washed with HBSS(Hank's balanced salt solution) to remove non-tumor tissue and necrotic tumor tissue in biosafety cabinet. After the tumor samples were cut into small fragments, they were incubated with collagenase solution at 37℃ for 1-2 hours. Then we collected the cells followed by removing the blood cells and fibroblast cells and the cell suspension was transferred to the HBSS washed capsules. For subcutaneous (s.c.) implantation, a small skin incision was made and the capsule was inserted through the subcutaneous tissue. Generally, each mouse received 4 capsules and drug administration was carried out for 7 days. The anti-tumor activity was evaluated through the CTG (cell viability) assay.

The combination of irradiated fibroblast feeder cells and Rho kinase inhibitor, Y-27632, conditionally induced an indefinite proliferative state in primary mammalian epithelial cells. These conditionally reprogrammed cells (CRCs) were karyotype-stable and nontumorigenic. Because self-renewal was a recognized property of stem cells, we investigated whether Y-27632 and feeder cells induced a stem-like phenotype. We found that CRCs shared characteristics of adult stem cells and exhibited up-regulated expression of α6 and β1 integrins, ΔNp63α, CD44, and telomerase reverse transcriptase, as well as decreased Notch signaling and an increased level of nuclear β-catenin. The induction of CRCs was rapid (occurs within 2 d) and resulted from reprogramming of the entire cell population rather than the selection of a minor subpopulation. CRCs did not overexpress the transcription factor sets characteristic of embryonic or induced pluripotent stem cells (e.g., Sox2, Oct4, Nanog, or Klf4). The induction of CRCs was also reversible, and removal of Y-27632 and feeders allowed the cells to differentiate normally. CRCs was called on the news human precision protocol. In the pancreatic cancer precision study, patients with inoperable or developed who acquired a little tissue could not build PDX and lost the chance of PDX treatment. Hence, we used the CRCs platform to grew tumor stem cell in vitro, when having adequate cells, we could do Mini-PDX or PDX drug assay[6].

In summary, as different stages of PC patients could not acquire precision personalized in clinical treatment at present, this study by CTC\PDX\Mini-PDX\CRs\RNA-SEQ\NGS (Next generation sequencing)platforms were predicted to provide precision diagnosis and treatment for different stages of PC patients. Meanwhile, we could build tumor information biobank, which provided ideal research materials and platforms for oncology basic research and translational medicine research.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • PDX,Mini-PDX,ctDNA,Conditional Reprogramming cells
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's planned enrollment of 100 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Drug guided by Mini-PDX/PDX

    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

  • No intervention
    Drug according to guideline

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

Interventions

  • ProcedureDrug guided by Mini-PDX/PDX

    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

06

What researchers measure

Primary outcomes

  1. OS

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

    Time frame: up to 24 months

Secondary outcomes

  1. DFS

    Observing and comparing DFS (disease free survival time) between two groups.

    Time frame: up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Changhai Hospital
    Shanghai, 200433, China
    • Shiwei Guo, Doctor · Contact · gestwa@163.com · +8618621500666
    • Gang Jin, Doctor · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 15317891 ↗
  • 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. PubMed 18591556 ↗
  • 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. PubMed 24553385 ↗
  • 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. PubMed 15120036 ↗
  • 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. PubMed 23169653 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2017 (actual). Primary completion is estimated for Dec 2024, 85 months after the start.

Of 352 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 71. This study's planned 85 months is above that.

Counting every sponsor, half of 373 studies reached it within 48 months; a quarter within 26 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2019
First posted
May 5, 2020
StartActual
Nov 10, 2017
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Sep 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04373928
Lead sponsor
Changhai Hospital
Responsible party
Guo ShiWei (Attending surgeon at the Institute of Pancreatic surgery, Changhai Hospital) — Principal investigator
First posted
May 5, 2020
Start date
Nov 10, 2017
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Sep 1, 2023

Study contacts

Guo Shiwei, M.D.
Contact
gestwa@163.com
18621500666
Jin Gang, M.D.
study chair · Department of general surgery, Changhai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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