Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients

Обзор

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.

Вмешательства

• Диагностический тест Single-cell Sequencing Analysis
  Identification of rare cell populations, the characterization of cell types and subtypes, and the discovery of novel cell states.

Первичные конечные точки

• Bioinformatics analysis of single-cell sequencing results [Срок оценки: Collected during surgical treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Fujian Medical University Union Hospital — Фучжоу

Публикации

• 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 PMID 35084987
• 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. PMID 31952776
• 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 PMID 32105518

Идентификаторы

NCT: NCT06310902 · 2024KY022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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