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.
Histologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium);
Meets one of the following conditions: Pathologically confirmed as moderately differentiated, moderately to poorly differentiated, or poorly differentiated; or pathologic staging as: T3N0M0, T1-3N1-2M0, T4N0-2M0; or one or more surgical margins are R1 resected (R0 resection if no tumor cells are found more than 1mm from the margin, otherwise R1 resection); or involvement of the portal vein and/or superior mesenteric vein resection; or pre-adjuvant chemotherapy CA19-9 > 90 U/mL; or pre-adjuvant chemotherapy ctDNA testing positive;
Completed standard treatment: Received radical resection, postoperative adjuvant therapy (including adjuvant chemotherapy based on gemcitabine or fluorouracil), and radiotherapy (if applicable);
Eligible for oral medication;
Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumor;
Incomplete macroscopic resection (R2 resection);
Presence of distant metastasis (including malignant ascites and pleural effusion, peritoneal metastasis) or locally recurrent pancreatic cancer;
CA19-9 > 180 U/mL within 21 days before enrollment;
Parallel
S-1
DrugTegafur, Gimeracil, and Oteracil Potassium (S-1) 40-60 mg per dose, orally (p.o.), twice daily (BID), from Day 1 to Day 28, with a 6-week cycle, for a total of 8 cycles; or from Day 1 to Day 14, with a 3-week cycle, for a total of 16 cycles.
Disease-Free Survival (DFS)
Disease-Free Survival (DFS) is defined as the time from enrollment to the first occurrence of disease recurrence or death from any cause, whichever occurs first. If no recurrence occurs during the study, DFS is defined as the time from enrollment to the last confirmed date of disease-free status. For participants who withdraw from the study for reasons other than recurrence (e.g., initiation of other treatments), DFS will be censored at the time of withdrawal or the start of other treatment. For participants who are not censored, pre-planned sensitivity analyses will be conducted based on radiologically confirmed recurrence or death. New primary tumors will not be considered as recurrence events. The confirmed recurrence date will be the date of imaging showing relapse. If recurrence is confirmed through other clinical methods, the date of diagnosis will be used.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from enrollment to death from any cause. For participants who are alive at the last follow-up, OS will be censored at the last known date of survival. In cases of participants lost to follow-up, OS will be censored at the last date they were confirmed to be alive.
Distant Disease-Free Survival (DDFS)
Distant Disease-Free Survival (DDFS) is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first. If no distant metastasis occurs, DDFS will be defined as the time from enrollment to the last confirmed date of no distant metastasis.
Local Recurrence-Free Survival (LRFS)
Local Recurrence-Free Survival (LRFS) is defined as the time from enrollment to the first occurrence of local recurrence or death from any cause, whichever occurs first. If no local recurrence occurs, LRFS will be defined as the time from enrollment to the last confirmed date of no local recurrence.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
This outcome will assess the number of participants who experience treatment-related adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. These events will be monitored and categorized based on severity, with a focus on the relationship to the study treatment.
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