A Randomized Phase II Clinical Trial to Evaluate the Efficacy Alternating mFOLFOX/mFOLFIRI Chemotherapy Regimen as a Second-line Treatment for Advanced Biliary Tract Cancer
In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin,efficacy of mFOLFOX/FOLFIRI vs mFOLFOX will be evaluated at randomized phase 2 trial.
• Age ≥ 19 years.
• Diagnosed with biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer.
• Either unresectable advanced disease or recurrence after curative surgery.
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-2
• First-Line Treatment Failure: Disease progression after at least one cycle of gemcitabine/cisplatin-based therapy or discontinuation of therapy due to adverse effects.
• Presence of evaluable or measurable lesions according to RECIST v1.1 criteria.
• Laboratory Criteria: optima bone marrow, liver, and kidney function within one week prior to enrollment: A. Hemoglobin \> 9.0 g/dL B. Absolute neutrophil count (ANC) \> 1,000/uL C. Platelet count \> 75,000/uL D. Serum creatinine \< 1.5× upper limit of normal (ULN) E. AST/ALT \< 3× ULN F. Total bilirubin \< 1.5× ULN (biliary drainage is allowed).
• Patients who understand the study protocol, can provide written informed consent, and are aware of their right to withdraw at any time without penalty.
• Effective Contraception (for patients of childbearing potential receiving oxaliplatin):
⁃ A. Male patients:
⁃ Must use effective contraception during the study and for 12 months after treatment completion.
⁃ B. Female patients:
⁃ Must use effective contraception during the study and for 15 months after treatment completion.