Actively Recruiting
Paclitaxel mIcelle Later-line cOmbined immunoTherapy for Biliary Tract Cancer
Led by Peking Union Medical College Hospital · Updated on 2025-09-08
100
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
After the standard first-line treatment, the treatment regimen was adjusted to a paclitaxel polymer micellar-based immunotherapy combination regimen
CONDITIONS
Official Title
Paclitaxel mIcelle Later-line cOmbined immunoTherapy for Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily agree and sign informed consent, be at least 18 years old, and comply with study follow-up regardless of gender.
- Diagnosed with advanced biliary carcinoma (unresectable, recurrent, locally advanced, or metastatic stage IIIA or above) including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
- No more than 2 organs with metastases including liver, lung, bone, and brain.
- Radical surgery or local treatments must be inappropriate for at least 4 weeks before baseline or due to disease progression, with acute toxic effects at or below grade 1.
- Intolerant or failed first-line systemic therapy for at least 1 month, with adverse events controlled at grade 1 or below.
- At least one measurable lesion per RECIST version 1.1 criteria.
- ECOG performance status 0-1 and expected survival of at least 3 months.
- Active hepatitis B or C patients must be receiving antiviral therapy and have controlled viral levels and liver function.
- Adequate hematology and organ function based on recent lab results.
- Any significant biliary obstruction must be resolved before enrollment.
- Adequate renal function with creatinine within specified limits.
- Women of childbearing potential must agree to use effective contraception or abstain from heterosexual intercourse during treatment and for 6 months after.
- Men must agree to use contraception or abstain from heterosexual intercourse and not donate sperm.
You will not qualify if you...
- Previous treatment with immune checkpoint inhibitors, lenvatinib, or paclitaxel, or known allergies or intolerance to these drugs or their components.
- Systemic anti-tumor treatment within 3 months prior to study including chemotherapy, targeted drugs, antibody drugs, or traditional Chinese medicines with anti-cancer effects.
- Currently undergoing systemic anti-cancer therapies including chemotherapy, immunotherapy, targeted therapy, or traditional Chinese medicine with clear indications within 4 weeks before randomization.
- Histopathology showing liver cancer, squamous cell carcinoma, sarcoma components, or ampullary carcinoma.
- Having other active or uncured malignant tumors within the past 5 years or simultaneously.
- Significant digestive tract diseases including fistulas grade 3 or above, bleeding disorders, or recent major gastrointestinal bleeding.
- Significant cardiovascular or cerebrovascular diseases within 6 months before enrollment.
- Liver and kidney insufficiency beyond specified limits or recent use of potent CYP3A4 inhibitors or inducers.
- Active or recent history of autoimmune diseases or immunosuppressive therapy except certain controlled conditions.
- Neurological disorders including untreated or active brain metastases, epilepsy needing medication, or cancerous meningitis.
- Persistent infectious diseases with grade higher than 2, active tuberculosis, or HIV infection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
J
Jiongyuan Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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