Maintenance Chemotherapy With S-1 vs. Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence/Metastasis

The goal of this real-world study is to learn if maintenance chemotherapy with Tegafur, Gimeracil, and Oteracil Potassium (S-1) can improve disease-free survival (DFS) compared to follow-up observation in patients with resected pancreatic cancer at high risk of recurrence or metastasis after adjuvant therapy. The main questions it aims to answer are: * Does maintenance therapy with S-1 improve disease-free survival (DFS) compared to follow-up observation after standard treatment for resected high-risk pancreatic cancer? * Does S-1 maintenance therapy improve overall survival (OS), distant disease-free survival (DDFS), and local recurrence-free survival (LRFS) compared to observation? * What are the safety and tolerability profiles of S-1 maintenance therapy compared to observation? Researchers will compare two groups: the S-1 maintenance therapy group and the observation-only group, to see if S-1 improves survival outcomes and safety. Participants will: * Receive maintenance chemotherapy with S-1 based on body surface area dosing or be assigned to the observation group without drug intervention. * Undergo imaging evaluations every 12 weeks to monitor for disease recurrence or metastasis. * Report side effects and any adverse events during the study.

NCT Number	NCT06779318
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University
Conditions	Pancreatic Cancer, Postoperative Adjuvant Therapy, Maintenance Therapy
Enrollment	464 participants
Start Date	2025-07
Primary Completion	2027-07 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2025-04-03