OncoMatch/Clinical Trials/NCT06454383
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
Is NCT06454383 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cholestyramine and Gemcitabine for advanced pancreatic adenocarcinoma.
Treatment: Cholestyramine · Gemcitabine · Leflunomide — This phase Ib trial tests the safety, side effects, and best dose of leflunomide in combination with gemcitabine in treating patients with pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and cannot be removed by surgery (unresectable). Improving the effectiveness of gemcitabine without increasing side effects could lead to a greater impact for pancreatic cancer patients' survival and quality of life. Gemcitabine is commonly used as a first-line chemotherapy treatment for pancreatic cancer. Leflunomide is a drug approved for use against rheumatoid arthritis that is being looked at as a cancer treatment option. It has shown promising results when combined with gemcitabine. Giving gemcitabine in combination with leflunomide may be safe and effective in treating patients with advanced unresectable pancreatic cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Chemotherapy ... within 21 days prior to day 1 of protocol therapy
Cannot have received: radiation therapy
radiation therapy ... within 21 days prior to day 1 of protocol therapy
Cannot have received: biological therapy
biological therapy ... within 21 days prior to day 1 of protocol therapy
Cannot have received: immunotherapy
immunotherapy within 21 days prior to day 1 of protocol therapy
Lab requirements
Blood counts
Without bone marrow involvement: ANC ≥ 1,500/mm^3 (no growth factor within 14 days unless cytopenia is secondary to disease involvement); Platelets ≥ 100,000/mm^3 (no platelet transfusions within 14 days unless cytopenia is secondary to disease involvement); Hemoglobin ≥ 9g/dL (no RBC transfusions within 14 days unless cytopenia is secondary to disease involvement)
Kidney function
Creatinine ≤ 1.5 x ULN OR creatinine clearance (Cockcroft Gault) of ≥ 50 mL/min for participants with a creatinine level of > 1.5 x ULN
Liver function
Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN (unless has Gilbert's disease total bilirubin ≤ 3 x ULN); AST ≤ 1.5 x ULN OR if liver metastases ≤ 3 x ULN; ALT ≤ 1.5 x ULN OR if liver metastases ≤ 2 x ULN
ANC ≥ 1,500/mm^3 ... Platelets ≥ 100,000/mm^3 ... Hemoglobin ≥ 9g/dL ... Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN ... AST ≤ 1.5 x ULN OR if liver metastases ≤ 3 x ULN ... ALT ≤ 1.5 x ULN OR if liver metastases ≤ 2 x ULN ... Creatinine ≤ 1.5 x ULN OR creatinine clearance (Cockcroft Gault) of ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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