Pancreatic cancer with liver metastasis
Conditions
Interventions
Experimental Group:Multimodal ablation combined with NARILIFOX chemotherapy and adbelimab
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Patients with pathologically or cytologically confirmed untreated pancreatic cancer with liver metastasis, without metastasis to other organs outside the liver; 3. Multiple liver metastases, with the largest liver metastatic lesion = 3 months; 7. Inclusion criteria for blood routine, biochemistry and main organ functions: (1) Bone marrow function: absolute neutrophil count >=2.0×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90g/L; (2) Liver function: defined as total bilirubin level =2, 24h urine should be collected and the 24h urine protein quantitative test should be proved to be <=1g; (4) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; If the patient is receiving anticoagulant therapy, PT is within the intended range of anticoagulant use. 8. For female subjects of childbearing potential, a negative urine or serum pregnancy test should be present within 7 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; For men, agree to use an adequate method of contraception or surgical sterilization during the trial and for 8 weeks after the last dose of study drug. 9. Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, his guardian must act as an agent for the informed consent process and sign the informed consent form. If the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), the informed consent process must be witnessed by a witness and the informed consent form must be signed.
Exclusion criteria
Exclusion criteria: 1. Previously received radiotherapy, interventional therapy, radiofrequency ablation, surgery, chemotherapy, immunotherapy, targeted therapy, or other investigational treatments for the current disease. 2. Allergic to drugs related to this study. 3. Currently participating in other interventional clinical research treatments. 4. Diagnosed with malignant diseases other than pancreatic cancer within 5 years prior to the first administration (excluding completely resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ). 5. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 related drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, OX-40, CD137). 6. Have received a solid organ or hematopoietic system transplant. 7. Any disease within 14 days prior to enrollment that required systemic treatment with corticosteroids (prednisone or equivalent medication at a daily dose >10 mg) or other immunosuppressive drugs. 8. Active autoimmune disease or history of autoimmune disease that may relapse. 9. Evidence in chest CT during the screening period of idiopathic pulmonary fibrosis, organic pneumonia (such as obliterative bronchiolitis), or a history of non-infectious pneumonia. 10. Severe infection within 4 weeks prior to enrollment (including but not limited to hospitalization for infection complications, sepsis, or severe pneumonia). 11. Severe chronic or active infection requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment (including tuberculosis infection, etc.). 12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive). 13. Meeting any of the following cardiovascular disease criteria: (1) Occurrence of New York Heart Association (NYHA) class II or higher heart disease within 3 months prior to starting study treatment. (2) Occurrence of major cardiovascular disease within 6 months prior to starting study treatment, including myocarditis, myocardial infarction, or cerebrovascular events, unstable arrhythmia, or unstable angina. (3) Symptomatic pulmonary embolism within =6 months prior to enrollment. (4) Known coronary artery disease or patients with left ventricular ejection fraction (LVEF) <40%. 14. Breastfeeding women. 15. Women of childbearing potential who are unwilling to use contraception. 16. Vulnerable populations other than the elderly/illiterate, including those with mental illness, cognitive impairment, critically ill patients, etc. 17. Any other reason the investigator deems the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR,objective response rate;CR, complete response;PR, partial response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy indicators (progression-free survival, overall survival, disease control rate, duration of response, clinical benefit rate, progression-free survival at 6 and 12 months, mortality at 6 and 12 months);Safety indicators (vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE), drug-related AE/SAE, and drug-specific AEs of this type (such as hypertension, proteinuria, and hand-foot syndrome)); | — |
Countries
China
Contacts
Public ContactXiao Liang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed