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Phase 3
Age: 18Years - 75Years
All Genders
ID05653453

Study of Tumor Treating Fields with Gemcitabine and Albumin-bound Paclitaxel for First-Line Treatment of Locally Advanced Pancreatic Cancer

Led by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd · Updated on 2025-03-24

512

Participants Needed

5

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining tumor treating fields with chemotherapy drugs gemcitabine and albumin-bound paclitaxel for people with locally advanced pancreatic cancer. This study is a phase 3 clinical trial focusing on patients whose cancer has not spread but meets specific criteria making it difficult to remove surgically. Participants are randomly assigned to one of two groups one group receives tumor treating fields along with chemotherapy, while the other group receives chemotherapy alone. Chemotherapy cycles last 28 days, with albumin-bound paclitaxel given intravenously on days 1, 8, and 15 at 125 mgm2, followed immediately by gemcitabine at 1000 mgm2. Tumor treating fields are used daily until disease progression or for up to 30 months. During the trial, participants will be monitored for overall survival up to 12 months after treatment ends, as well as progression-free survival and adverse events throughout the study period. Researchers will assess measurable lesions, safety, and quality of life. Participants will undergo regular medical evaluations, imaging, and laboratory tests to track treatment effects and side effects over time.

CONDITIONS

Brief Title

Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer

Research Team

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