Actively Recruiting
Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer
Led by Peking Union Medical College Hospital · Updated on 2025-12-09
60
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent.
- Age over 18 years with no gender restriction.
- Histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
- No prior treatment for unresectable or metastatic disease.
- Previous curative surgery with disease recurrence after more than 6 months or completed adjuvant therapy and disease-free for more than 6 months.
- At least one measurable lesion as defined by RECIST 1.1.
- ECOG performance status score of 0-1 within one week before enrollment.
- Estimated survival time of 3 months or more.
- For patients with active hepatitis B or C, appropriate antiviral treatment with HBV-DNA <2000 IU/ml and liver function within CTCAE Grade 1 elevation.
- Adequate hematological and organ functions based on recent laboratory tests.
- Women of childbearing potential and male participants agree to use effective contraception during treatment and for at least 6 months after last dose.
You will not qualify if you...
- Previous systemic treatment for biliary tract cancer.
- ECOG score greater than 1.
- Diagnosis of pancreatic cancer.
- Pregnant or breastfeeding women.
- Known allergy or intolerance to PD-1 monoclonal antibodies, lenvatinib, or components.
- Received local anti-tumor treatment within 4 weeks before study drug.
- Grade 3 or higher gastrointestinal or non-gastrointestinal fistula.
- Conditions affecting oral administration of lenvatinib.
- Major surgery within 4 weeks or minor surgery within 7 days before study drug.
- Significant cardiovascular or cerebrovascular diseases within 6 months.
- Hepatic or renal dysfunction with specified laboratory abnormalities.
- Persistent infection above grade 2.
- History of thrombotic events within past 6 months.
- Poorly controlled hypertension despite medication.
- Active or recent autoimmune diseases requiring systemic immunosuppressive therapy.
- Active central nervous system metastasis or carcinomatous meningitis.
- Planned or prior organ or bone marrow transplantation.
- Active tuberculosis infection.
- Recent or ongoing gastrointestinal bleeding or bleeding disorders.
- Known HIV infection.
- Active hepatitis B or C without regular treatment.
- Severe non-healing wounds, ulcers, or fractures.
- History of substance abuse or conditions affecting compliance or safety.
- Unresolved toxicity greater than grade 1 from prior treatments.
- Severe pulmonary impairment.
- Recent use of strong CYP3A4 inhibitors or inducers.
- Concurrent malignancy not cured within past 5 years, except certain treated cancers.
- Investigator determination of unsuitability.
- Concurrent participation in another clinical study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
H
haitao Zhao, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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