Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

Explore the impact of the first-line application of Pembrolizumab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers

Eligibility criteria

Qualifiers

• The subjects voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.

They are over 18 years of age and gender is not restricted when signing the informed consent form.

They have histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.

Patients who are diagnosed with unresectable or metastatic disease and have not received prior treatment are eligible for inclusion.

Disqualifiers

• Previous systemic treatment received.

ECOG score > 1.

Pancreatic cancer.

Pregnant (positive pregnancy test before medication) or breastfeeding women.

Trial design

Treatments tested in this trial

  • Pembrolizumab,Lenvatinib and Gemox Chemotherapy(Gemcitabine and Oxaliplatin)
  • Pembrolizumab and Lenvatinib
  • Pembrolizumab and Gemox Chemotherapy(Gemcitabine and Oxaliplatin)

Treatment groups

60 Participants
are divided into 3 treatment groups