Actively Recruiting
A Phase II Study of Cryoablation Combined with Anti-PD-1 Antibody (SHR-1210) in Patients with Advanced Intrahepatic Cholangiocarcinoma
Led by Fudan University · Updated on 2025-02-27
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining cryoablation with an anti-PD-1 antibody treatment called Camrelizumab in patients with advanced intrahepatic cholangiocarcinoma who have not responded to first-line systemic therapy. This phase II study is based on evidence that cryoablation may activate immune cells by destroying tumor tissue, while the anti-PD-1 antibody blocks regulatory signals on T cells to enhance immune response against cancer. Participants receive cryoablation treatment starting on day 1. Two weeks later, Camrelizumab is given by intravenous infusion every three weeks at a dose of 3 mg/kg. Treatment continues until the disease progresses, unacceptable side effects occur, the participant chooses to stop, or consent is withdrawn. The cryoablation uses a two-cycle freeze-thaw protocol guided by ultrasound or CT imaging to target the tumor. During the study, participants will have regular evaluations including imaging scans like CT or MRI to measure tumor response according to RECIST criteria. Researchers will monitor the objective response rate over up to 24 months, along with secondary measures such as duration of response, progression-free survival, overall survival, disease control rate, and adverse events up to 42 months. Participants will also undergo lab tests and physical assessments to track safety and overall health throughout the study duration.
CONDITIONS
Brief 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 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 tumor site by RECIST criteria on CT or MRI.
- Performance status (ECOG) of 2 or less.
- Life expectancy of at least 12 weeks.
- Adequate blood counts, liver enzymes, and kidney function within specified limits.
- Negative pregnancy test within 7 days before starting trial for females of reproductive potential.
- Willing and able to comply with study 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 like stroke, deep vein thrombosis, or pulmonary embolism within 6 months before study drug.
- Radiofrequency ablation, resection, or radiotherapy within 4 weeks before study treatment.
- Major surgery within 4 weeks or not recovered from major surgery effects.
- Second primary cancer except treated basal skin cancer or cervical carcinoma in-situ.
- Immunocompromised status, including HIV infection.
- Participation in another clinical trial with investigational products within 30 days or 7 half-lives.
- Conditions interfering with treatment evaluation or safety, including interstitial lung disease, HBV and HCV coinfection, pancreatitis, active infections, organ transplant history, immunodeficiency, recent immunosuppressive therapy, active autoimmune disease requiring systemic treatment, or recent live vaccine.
- CNS metastases unless asymptomatic and off steroids for 6 weeks with completed local therapy.
- Medication interfering with trial agents.
- Any other effective cancer treatment except study treatment at start.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies.
- Pregnancy, breastfeeding, or not using effective contraception for patients of reproductive potential.
- Significant 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression or discontinuation
Participants receive cryoablation treatment starting on day 1, followed by anti-PD-1 antibody (Camrelizumab) administered every three weeks starting on day 14 until disease progression, unacceptable toxicity, participant request, or withdrawal of consent.
Regular visits every three weeks for Camrelizumab administration
Duration - Up to 18 months after treatment completion, totaling up to 42 months
Participants are monitored for safety and survival outcomes after treatment ends.
Visits scheduled periodically for safety and survival assessments
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
P
Peng Wang, MD
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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