Neoadjuvant chemotherapy for localized pancreatic cancer
Peri-operative S-1/Leucovorin, Oxaliplatin and Gemcitabine (SLOG) for Localized Pancreatic Cancer
This study is testing a new chemotherapy treatment called SLOG for people with localized pancreatic cancer to see if it works better than standard treatments before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Health Research Institutes, Taiwan Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Kaohsiung and 2 other locations) |
| Trial ID | NCT05048524 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a neoadjuvant chemotherapy regimen known as SLOG in patients with localized pancreatic ductal adenocarcinoma. The study aims to determine how well this treatment works compared to traditional approaches, particularly focusing on patients who may not receive adjuvant chemotherapy after surgery. Participants will undergo biopsy for histological diagnosis and provide tumor tissue samples for biomarker analysis before and after treatment. The trial is designed to assess the feasibility of the SLOG regimen in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and above with localized resectable or potentially resectable pancreatic cancer who have not received prior treatment.
Not a fit: Patients with unresectable pancreatic cancer or those who have received prior treatment for pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with localized pancreatic cancer by increasing the number of individuals who can receive effective chemotherapy.
How similar studies have performed: Previous studies have shown promising results with similar neoadjuvant approaches, indicating potential for success with the SLOG regimen.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A. Localized resectable or potentially resectable pancreatic cancer as determined by image modality; resectability is determined by the treating surgeon No prior treatment for pancreatic cancer B. Patients must agree to receive biopsy for histological diagnosis and provide residual tissue for biomarker analysis before chemotherapy C. Patients must agree to provide tissue for biomarker analysis after neoadjuvant chemotherapy, either surgical specimen or follow-up biopsy in unsectable disease D. At least one measurable lesion according to RECIST version 1.1 E. Ability to understand and willingness to sign a written informed consent document. F. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 G. Age of 20 years or above H. Life expectancy of at least 12 weeks I. Adequate organ function as defined by the following criteria: * absolute neutrophil count (ANC) ≥ 1,500/mm3 * hemoglobin level ≥ 9 g/dL * platelet count ≥ 100,000/mm3 * total bilirubin \< 2 mg/dL * aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) * creatinine clearance rate (CCr) ≥ 50 mL/min (24-hour urine collection or calculated by Cockroft-Gault formula; male: \[(140 - age) × weight (kg)\]/\[72 × serum creatinine(mg/dL)\];female=male x 0.85 J. Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study. Exclusion Criteria: A. Other malignancy within the past 5 years except for adequately treated localized skin cancer or cervical cancer in situ; B. Presence of distant metastasis; C. Presence of mental disease or psychotic manifestation; D. Active or uncontrolled infection; E. Significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications at physician discretion F. Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. G. History of active autoimmune disease within 3 years or use of steroid more than prednisolone 10mg/day.
Where this trial is running
Kaohsiung and 2 other locations
- Kaohsiung Medical University Hospital — Kaohsiung, Taiwan (Recruiting)
- National Cheng-Kung University Hospital — Tainan, Taiwan (Recruiting)
- National Institute of Cancer Research — Tainan, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.