OncoMatch/Clinical Trials/NCT07146646
Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer
Is NCT07146646 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trifluridine/tipiracil and Oxaliplatin for biliary tract cancer.
Treatment: Trifluridine/tipiracil · Oxaliplatin — Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine/tipiracil (FTD/TPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD/TPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — advanced or metastatic
Participants must have received only one line of systemic therapy for advanced or metastatic BTCs.
Cannot have received: investigational therapy
Exception: if >4 weeks or >5 half-lives since last dose
Participant has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).
Cannot have received: systemic therapy
Exception: adjuvant therapy will not be counted as line of systemic therapy
Received more than one line of systemic therapy for bile duct cancer. Adjuvant therapy will not be counted as line of systemic therapy.
Cannot have received: systemic steroid therapy
Exception: ≤10mg prednisone or equivalent, or >7 days prior to first dose
Receiving systemic steroid therapy (>10mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Cannot have received: trifluridine/tipiracil (trifluridine/tipiracil)
Prior treatment with FTD/TPI
Cannot have received: oxaliplatin (oxaliplatin)
Prior treatment with oxaliplatin
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Platelet count ≥75,000/mcL
Kidney function
Serum Creatinine ≤ 1.5 x ULN or creatinine clearance ≥60 mL/min for participants with creatinine levels >1.5 x ULN (Cockcroft-Gault method)
Liver function
AST (SGOT) ≤ 2.5 X institutional ULN or ≤ 5 × ULN for participants with liver metastases; ALT (SGPT) ≤ 2.5 X institutional ULN or ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels >1.5 x ULN
Participants must have organ and marrow function as defined below: * Absolute neutrophil count ≥ 1,500/mcL * Platelet count ≥75,000/mcL * AST (SGOT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels >1.5 x ULN * Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL/min for participants with creatinine levels >1.5 x ULN (Cockcroft-Gault method)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center · Cleveland, Ohio
- Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center · Cleveland, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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