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

Recruiting

• Conditions: Pancreatic Neoplasms

• Registration Number: NCT06310902
• Lead Sponsor: Fujian Medical University Union Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-03-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioinformatics analysis of single-cell sequencing results	Collected during surgical treatment	Using single-cell sequencing technology, in-depth analysis of surgical samples from resectable/borderline resectable pancreatic cancer patients is conducted to investigate the composition and interactions of the tumor microenvironment in pancreatic cancer.

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China