Peri-operative SLOG for Localized Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2023-08-24
• Target enrollment: 0
• Participant gender: All

Summary

1. To evaluate the efficacy of neoadjuvant chemotherapy SLOG in localized pancreatic cancer

2. To evaluate the safety profile in patients with pancreatic cancer who receive neoadjuvant SLOG

3. To collect tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Treatments: Gemcitabine; Leucovorin; Oxaliplatin

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.