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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат S-1
  Tegafur, 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.

Первичные конечные точки

• Disease-Free Survival (DFS) [Срок оценки: Up to 3 years]

Вторичные конечные точки (5)

• Overall Survival (OS) [Срок оценки: 5 years]
• Distant Disease-Free Survival (DDFS) [Срок оценки: Up to 3 years]
• Local Recurrence-Free Survival (LRFS) [Срок оценки: Up to 3 years]
• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [Срок оценки: Up to 3 years]
• Quality of Life (QoL) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• 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;
• Age ≥18 and ≤75, male or female;
• ECOG performance status: 0 to 2;
• 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;
• 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;
• Expected survival time ≥6 months;
• Voluntary participation in the study, signed informed consent, and demonstrated good compliance and cooperation during follow-up.

Критерии исключения

• 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;
• 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;
• Known peripheral neuropathy (CTCAE ≥ Grade 2);
• 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;
• 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);
• Factors that significantly affect oral drug absorption, such as difficulty swallowing, chronic diarrhea, or gastrointestinal obstruction; uncontrolled Crohn's disease or ulcerative colitis;
• Clinically symptomatic serous effusions (including pleural effusion, ascites, pericardial effusion) requiring symptomatic treatment;
• Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to take effective contraceptive measures;
• Known allergy to the investigational drug, the class of the investigational drug, or its components;
• Need for systemic corticosteroid treatment (except for local steroid pre-treatment);
• History of interstitial lung disease (including interstitial pneumonia, pulmonary fibrosis, etc.) or CT findings of interstitial lung disease;
• Active local or systemic infection requiring treatment;
• Heart failure NYHA classification ≥ II or severe heart disease;
• Known HIV infection or history of acquired immunodeficiency syndrome (AIDS) or active hepatitis B or C;
• Toxicity not recovered (CTCAE > Grade 1) or previous anticancer surgery not fully recovered;
• Patients deemed unsuitable for this study by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT06779318 · MSPAC-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗