Actively Recruiting
TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma
Led by Fudan University · Updated on 2025-02-27
25
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy.
CONDITIONS
Official Title
TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained.
- Age 18 years or older at study entry.
- Unresectable or metastatic intrahepatic cholangiocarcinoma confirmed by histology or cytology.
- Failed one line of systemic treatment for advanced cholangiocarcinoma due to progression or toxicity.
- At least one measurable disease site per RECIST1.1 criteria by CT or MRI.
- Performance status of 0 to 2 on the ECOG scale.
- Life expectancy of at least 12 weeks.
- Adequate blood counts and organ function as specified (neutrophils ≥1500/L, platelets ≥75 x10³/L, bilirubin ≤3x upper normal limit, AST and ALT ≤5x upper normal limit, INR ≤1.25, albumin ≥31 g/dL, serum creatinine ≤1.5x ULN or creatinine clearance ≥30 mL/min).
- Negative pregnancy test within 7 days before trial start for females of reproductive potential.
- Willing and able to follow study protocol including treatments, contraceptive measures, visits, and examinations including follow-up.
You will not qualify if you...
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks before treatment.
- Thrombotic or embolic events (e.g., stroke, deep vein thrombosis, pulmonary embolism) within 6 months before first dose, except segmental portal vein thrombosis.
- Radiofrequency ablation or tumor resection within 4 weeks prior to treatment.
- Radiotherapy within 4 weeks prior to treatment.
- Major surgery within 4 weeks before treatment or not recovered from surgery effects.
- Presence of second primary cancer except treated basal skin cancer or cervical carcinoma in situ.
- Immunocompromised status (e.g., HIV positive).
- Participation in another investigational study within 30 days or 7 half-lives of prior trial drug.
- Conditions interfering with treatment evaluation or safety including interstitial lung disease, HBV and HCV coinfection, pancreatitis, active tuberculosis or infections, history of organ transplant, immunodeficiency, recent systemic steroid or immunosuppressive therapy, active autoimmune disease requiring systemic treatment within 3 months (with certain exceptions), recent live vaccine, CNS metastases with exceptions, interfering medications.
- Prior therapy with certain immune checkpoint or co-stimulatory antibodies.
- Pregnant, breastfeeding, or not using effective contraception if of reproductive potential.
- History of non-compliance or inability to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here