Actively Recruiting
Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis
Led by Fudan University · Updated on 2025-02-27
25
Participants Needed
1
Research Sites
260 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 Sintilimab plus regorafenib for patients with colorectal cancer liver metastasis in the third-line setting.
CONDITIONS
Official Title
Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained.
- Age 18 years or older at study entry.
- Diagnosed with colorectal cancer liver metastasis.
- Failed at least two previous systemic chemotherapy regimens including fluorouracil, oxaliplatin, and irinotecan for liver metastases.
- Previous antiangiogenic or anti-EGFR therapy allowed.
- At least one measurable tumor site by RECIST criteria using spiral CT or MRI.
- Performance status of 2 or less on the ECOG scale.
- Life expectancy of at least 12 weeks.
- Adequate blood counts and organ function as specified.
- Female patients with reproductive potential must have a negative pregnancy test within 7 days before starting.
- Willing and able to comply with study protocol including treatment 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 before study drug except segmental portal vein thrombosis.
- Prior cryoablation or regorafenib treatment.
- Radiofrequency ablation or surgery within 4 weeks before treatment.
- Radiotherapy within 4 weeks before treatment.
- Major surgery within 4 weeks before treatment or not recovered from surgery.
- Second primary cancer except treated basal skin cancer or cervical carcinoma in-situ.
- Immunocompromised status including HIV positive.
- Participation in another investigational study within 30 days or 7 half-lives of previous drug.
- Conditions interfering with treatment evaluation or safety including interstitial lung disease, HBV/HCV coinfection, pancreatitis, active infections, organ transplant history, immunodeficiency, recent systemic steroid or immunosuppressive therapy, active autoimmune disease requiring systemic treatment within 3 months (with some exceptions), live vaccine within 30 days before or during treatment.
- CNS metastases unless asymptomatic and off steroids for 6 weeks.
- Medications interfering with study drugs.
- Other cancer treatments besides protocol treatment at study start.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies.
- Pregnant or breastfeeding women or those not using effective contraception.
- History of non-compliance or inability to give reliable informed consent.
AI-Screening
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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
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