Actively Recruiting
Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma
Led by Fudan University · Updated on 2025-08-12
56
Participants Needed
1
Research Sites
101 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 QL1706 (iparomlimab/tuvonralimab) in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.
CONDITIONS
Official Title
Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) 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 intrahepatic cholangiocarcinoma confirmed by histology or cytology.
- Failed one line of systemic treatment due to progression or toxicity: Cohort A progressed after GemCis plus PD1/PD-L1 inhibitor; Cohort B progressed after GemCis plus PD1/PD-L1 inhibitor and anti-vascular endothelial growth factor antibody or tyrosine kinase inhibitors.
- At least one measurable disease site by RECIST with 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.
- Negative pregnancy test within 7 days prior to trial start for females of reproductive potential.
- Willing and able to follow protocol including treatment, contraception, visits, and 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 within 6 months prior to first study dose, except segmental portal vein thrombosis.
- Prior cryoablation treatment.
- Radiofrequency ablation (RFA) or surgery less than 4 weeks before study treatment.
- Radiotherapy less than 4 weeks before study treatment.
- Major surgery within 4 weeks before starting treatment or incomplete recovery from surgery.
- Second primary cancer except treated basal skin cancer or cervical carcinoma in-situ.
- Immunocompromised status such as HIV positive.
- Participation in another clinical trial with investigational products within 30 days or 7 half-lives of prior medication.
- Conditions interfering with treatment evaluation or safety including interstitial lung disease, co-infections with HBV and HCV, pancreatitis, active tuberculosis, other infections needing systemic therapy, organ transplant history, immunodeficiency, recent immunosuppressive therapy, active autoimmune disease requiring recent systemic treatment (with exceptions), recent live vaccine, CNS metastases unless asymptomatic and steroid-free for 6 weeks.
- Medications interfering with study drugs.
- Use of other cancer treatments outside protocol at study start.
- Previous investigational product use within 28 days.
- Prior therapy with anti-CD137 or anti-CTLA-4 antibodies.
- Pregnancy, breastfeeding, or not using effective birth control methods.
- History of non-compliance or inability to give reliable 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
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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