Peri-operative SLOG for Localized Pancreatic Cancer (NCT05048524) | Clinical Trial Compass
UnknownPhase 2
Peri-operative SLOG for Localized Pancreatic Cancer
Taiwan64 participantsStarted 2021-09-03
Plain-language 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
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 with…
What they're measuring
1
The percentage of subjects with R0 resection after surgery
Timeframe: 1 year
Trial details
NCT IDNCT05048524
SponsorNational Health Research Institutes, Taiwan