Actively Recruiting
Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01)
Led by Fudan University · Updated on 2025-04-06
92
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus Tislelizumab compared with FOLFOX in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.
CONDITIONS
Official Title
Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- At least 18 years old at study entry
- Have unresectable or metastatic intrahepatic cholangiocarcinoma confirmed by tissue or cells
- Have failed 1 systemic treatment for advanced cholangiocarcinoma due to progression or toxicity
- Have at least one measurable disease site by CT or MRI per RECIST criteria
- Have performance status of 0, 1, or 2 on the ECOG scale
- Have life expectancy of at least 12 weeks
- Have adequate blood counts and organ function as defined by study requirements
- Female participants with reproductive potential must have a negative pregnancy test within 7 days before starting the trial
- Willing and able to comply with study treatments, contraceptive measures, visits, and follow-up
You will not qualify if you...
- History of heart disease or significant gastrointestinal bleeding within 4 weeks before starting study treatment
- Blood clots or embolic events in the past 6 months except segmental portal vein thrombosis
- Prior treatment with cryoablation
- Prior treatment with lenvatinib or other targeted therapy
- Radiofrequency ablation or surgery less than 4 weeks before starting study treatment
- Radiotherapy less than 4 weeks before starting study treatment
- Major surgery within 4 weeks before starting treatment or not recovered from surgery effects
- Second primary cancer except treated basal skin cancer or cervical carcinoma in-situ
- Immunocompromised status including HIV infection
- Participation in another trial with investigational drug within 30 days or 7 half-lives of prior drug
- Conditions interfering with treatment evaluation or safety including interstitial lung disease, certain infections, organ transplant, immunodeficiency, recent immunosuppressive therapy, active autoimmune disease requiring treatment, recent live vaccine, or CNS metastases unless meeting specific criteria
- Use of medications interfering with study drugs
- Any other cancer treatment except study treatment at start
- Prior investigational product within 28 days
- Prior therapy with anti-CD137 or anti-CTLA-4 antibodies
- Pregnant, breastfeeding, or not using effective contraception if of reproductive potential
- History of non-compliance or inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
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
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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