Clinical trial · Interventional
Personalized Precision Diagnosis and Treatment of Pancreatic Cancer
A Single-centric, Prospective, Open, Interventional Clinical Trial, About Personalized Precision Diagnosis and Treatment of Pancreatic Cancer
- 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)
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.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug guided by Mini-PDX/PDX | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Drug guided by Mini-PDX/PDX
- description
- 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.
- interventionNames
- Procedure: Drug guided by Mini-PDX/PDX
- type
- NO_INTERVENTION
- label
- Drug according to guideline
- description
- The drugs (gemcitabine, Nab-paclitaxel, S-1) are used ccording to NCCN pancreatic cancer guideline。
Primary outcomes (1)
- measure
- OS
- timeFrame
- up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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: * 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.
References
Publications (5)
- RESULTCristofanilli 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 15317891
- RESULTCohen 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 18591556
- RESULTBettegowda 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 24553385
- RESULTFiebig 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 15120036
- RESULTSuprynowicz 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.