mFOLFOX/mFOLFIRI vs. mFOLFOX in Advanced or Recurrent Biliary Tract Cancer Second-line

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-99
SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients with prior exposure to oxaliplatin or irinotecan in previous cancer treatments.

Patients with metastatic or unresectable biliary tract cancer who have received second- line or higher chemotherapy.

Pregnant or breastfeeding women.

Patients with a history of other malignancies within the past 3 years, except for papillary or follicular thyroid cancer.

Trial design

Treatments tested in this trial

  • Oxaliplatin, 5FU, leucovorin
  • Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,

Treatment groups

130 Participants
are divided into 2 treatment groups