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

StatusNot Yet Recruiting
PhasePhase 4
Started2025-07
View on ClinicalTrials.gov ↗

Amendment history

2025-04-02
minor
Study Identification, Study Status v1
Primary completion date2027-01→2027-07
Completion date2028-04→2028-07
Start date2025-04→2025-07
Study titlerevised
Maintenance Chemotherapy withWith S-1 Vsvs. Observation After Adjuvant Therapy for Resected Pancreatic Cancer withWith High Risk of Recurrence/Metastasis
2025-01-13
minor
Original filing
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.
Trial Details
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