Clinical trial NCT06310902: Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients
Official title: Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Neoplasms
Keywords: Pancreatic neoplasms
Single-cell sequencing
Immune microenvironment
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resectable/borderline resectable pancreatic cancer patients diagnosed based on pathological and preoperative imaging evaluation

Brief summary: Preoperative neoadjuvant chemotherapy is widely used in treating patients with borderline resectable pancreatic cancer (BRPC). However, there are limitations in this field. Treatment strategies and definitions for BRPC patients differ, and the efficacy and prognosis of neoadjuvant chemotherapy vary greatly.This study aims to utilize single-cell sequencing technology to investigate in-depth the composition and interactions of the tumor microenvironment in patients from the surgical-only group and the preoperative neoadjuvant chemotherapy group.


Eligibility criteria: Inclusion Criteria:

* 18 years ≤ age ≤ 75 years.
* Resectable/borderline resectable pancreatic cancer patients diagnosed based on pathological and preoperative imaging evaluation.
* No prior history of any form of anti-tumor treatment.
* At least one measurable lesion.
* Eastern Cooperative Oncology Group (ECOG): 0-1.
* Not participated in any other clinical studies before or during treatment.
* Willingness to participate voluntarily in this study, signing an informed consent form.

Exclusion Criteria:

* History of any other malignant tumor, except for completely resected basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, within the past 5 years.
* Vaccination with live vaccines within 4 weeks prior to enrollment or during the study period.
* Active autoimmune diseases or a history of autoimmune diseases within the past 4 weeks before enrollment.
* Allogeneic bone marrow or organ transplantation.
* Active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors in the gastrointestinal tract, or other conditions determined by the investigator that may cause gastrointestinal bleeding or perforation.
* Evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding \>30 mL within 3 months, hematemesis, melena, or hematochezia), hemoptysis (\>5 mL of fresh blood within 4 weeks), or occurrence of thromboembolic events within 12 months (including stroke events and/or transient ischemic attacks).

Primary outcomes:
measure: Bioinformatics analysis of single-cell sequencing results
timeFrame: Collected during surgical treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
citation: Versteijne E, van Dam JL, Suker M, Janssen QP, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Tienhoven G, van Eijck CHJ; Dutch Pancreatic Cancer Group. Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. J Clin Oncol. 2022 Apr 10;40(11):1220-1230. doi: 10.1200/JCO.21.02233. Epub 2022 Jan 27.
citation: Gonzalez-Silva L, Quevedo L, Varela I. Tumor Functional Heterogeneity Unraveled by scRNA-seq Technologies. Trends Cancer. 2020 Jan;6(1):13-19. doi: 10.1016/j.trecan.2019.11.010. Epub 2020 Jan 3.
citation: Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. doi: 10.1200/JCO.19.02274. Epub 2020 Feb 27.