Actively Recruiting
Cryoablation Combined with Anti-PD-1 Antibody in Patients with Advanced Intrahepatic Cholangiocarcinoma
Led by Fudan University · Updated on 2025-02-27
25
Participants Needed
1
Research Sites
338 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 cryoablation combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma after progression on first line systemic therapy.
CONDITIONS
Official Title
Cryoablation Combined with Anti-PD-1 Antibody 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 time of study entry.
- Unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma.
- Failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.
- At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.
- Performance status of 2 or less on the ECOG scale.
- Life expectancy of at least 12 weeks.
- Adequate blood counts, liver enzymes, and kidney function within specified limits.
- Female patients with reproductive potential must have a negative pregnancy test within 7 days prior to trial start.
- Willing and able to comply with study protocol including treatment, contraceptive measures, visits, and exams.
You will not qualify if you...
- History of cardiac disease or clinically significant gastrointestinal bleeding within 4 weeks prior to study treatment.
- Thrombotic or embolic events within 6 months prior to first dose, except segmental portal vein thrombosis.
- Radiofrequency ablation or resection within 4 weeks prior to study treatment.
- Radiotherapy within 4 weeks prior to study treatment.
- Major surgery within 4 weeks prior to study or not recovered from its effects.
- Second primary cancer except treated basal skin cancer or carcinoma in-situ of the cervix.
- Immunocompromised status, including HIV positive.
- Participation in another clinical study with investigational product within last 30 days or 7 half-lives of prior medication.
- Conditions interfering with treatment evaluation or safety including interstitial lung disease, HBV and HCV co-infection, pancreatitis, active infections, organ transplant history, immunodeficiency, recent systemic steroid or immunosuppressive therapy, certain autoimmune diseases, recent live vaccine, CNS metastases without meeting exceptions.
- Medications interfering with trial agents.
- Use of other cancer treatments besides protocol-specified treatments at study start.
- Prior therapy with certain immune checkpoint inhibitors.
- Pregnancy, breastfeeding, or lack of effective contraception for reproductive potential.
- Significant history of non-compliance or inability to provide informed consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
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
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