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

A Real-World Study Comparing Maintenance Chemotherapy With Tegafur, Gimeracil, and Oteracil Potassium (S-1) Versus Follow-Up Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence/Metastasis (MSPAC-1)

NCT06779318•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium);
•2. 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;
•3. Completed standard treatment: Received radical resection, postoperative adjuvant therapy (including adjuvant chemotherapy based on gemcitabine or fluorouracil), and radiotherapy (if applicable);
•4. Eligible for oral medication;
•5. Age ≥18 and ≤75, male or female;
•6. ECOG performance status: 0 to 2;
•7. Normal function of major organs as per the following criteria within 14 days prior to starting treatment:① Neutrophil count ≥ 1.5×10\^9/L;② Platelet count ≥ 75×10\^9/L;③ Hemoglobin ≥ 9.0 g/dL;④ AST ≤ 2.5×UNL (upper normal limit) (if liver metastasis present, AST ≤ 5×UNL);⑤ ALT ≤ 2.5×UNL (if liver metastasis present, ALT ≤ 5×UNL);⑥ Total bilirubin ≤ 1.5×UNL;⑦ Creatinine clearance (calculated using the Cockcroft-Gault formula) \> 60 mL/min or serum creatinine ≤ 1.5×UNL;
•8. Women of childbearing potential must have used reliable contraception within 7 days prior to enrollment and have a negative pregnancy test, and must be willing to use appropriate contraception during the study and for 6 months after the last dose of the investigational drug. For men, they must be surgically sterile or agree to use appropriate contraception during the study and for 3 months after treatment;
•9. Expected survival time ≥6 months;
•10. Voluntary participation in the study, signed informed consent, and demonstrated good compliance and cooperation during follow-up.

Exclusion Criteria

•1. Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumor;
•2. Incomplete macroscopic resection (R2 resection);
•3. Presence of distant metastasis (including malignant ascites and pleural effusion, peritoneal metastasis) or locally recurrent pancreatic cancer;
•4. CA19-9 \> 180 U/mL within 21 days before enrollment;
•5. Severe liver dysfunction (AST/ALT \> 3.5 times the upper limit of normal, alkaline phosphatase \> 6 times the upper limit of normal), with liver drainage;
•6. Known peripheral neuropathy (CTCAE ≥ Grade 2);
•7. Participation in another clinical trial of cytotoxic drugs, targeted therapies, immunotherapies, etc., within the past 4 weeks, or received systemic chemotherapy, radiotherapy, or biological therapy within the past 4 weeks;
•8. Concurrent or metachronous cancers with disease-free survival ≥ 5 years (excluding pancreatic cancer), except for cancers that have been cured or can be potentially cured with local excision (e.g., esophageal cancer, gastric cancer, colorectal cancer, cervical cancer, non-melanoma skin cancer, bladder cancer);
•9. Factors that significantly affect oral drug absorption, such as difficulty swallowing, chronic diarrhea, or gastrointestinal obstruction; uncontrolled Crohn's disease or ulcerative colitis;
•10. Clinically symptomatic serous effusions (including pleural effusion, ascites, pericardial effusion) requiring symptomatic treatment;
+9 more criteria

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

July 1, 2025

Primary Completion Date

July 1, 2027

Completion Date

July 1, 2028

Last Updated

April 3, 2025

Enrollment

464

ESTIMATED participants

Conditions

Pancreatic CancerPostoperative Adjuvant TherapyMaintenance Therapy

Interventions

S-1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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