unresectable intrahepatic cholangiocarcinom
Conditions
Interventions
Case series:Lenvatinib plus treprizumab, an inhibitor of PD1
Sponsors
The Second Affiliated hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. Histologically confirmed ICC; 3. Detection of extrahepatic metastases other than the brain or meninges; 4. At least one measurable lesion defined by RECIST v1.1, or a measurable lesion with definite progress after local treatment (based on RECIST V1.1 standard); 5. liver function at Child-Pugh A level; 6. ECOG PS=1.5x10^9/L.The platelet count (PLT)>=75x10^9/L and hemoglobin (HGB) >=9.0 g/dL; 2) Liver function: total bilirubin (TBIL) =28 g/L; alkaline phosphatase(ALP) =50 mL/min (Cockcroft-Gault formula); urine routine results showed that urine protein =2+, patients should be collected 24 hours and 24 hours' Quantitative <1g; 4) Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT)<= 1.5 ULN; 8. Sign written informed consent, and be able to comply with the program requirements of visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Mixed hepatocellular-cholangiocarcinoma; 2. Had received any multi-kinase therapy. Previously, had received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy.Had received targeted therapies against the signaling pathways of vascular endothelial growth factor and/or vascular EGFR, RAF, MEK, PDGFR, and FGFR; 3. known brain or meningeal metastasis; 4. cancer thrombus involving the main portal vein or inferior vena cava; 5. Local-regional treatment of the liver within four weeks prior to admission; 6. Interstitial pulmonary disease, non-infectious pneumonia or uncontrolled pneumonia History of systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute pulmonary disease, etc.; 7. The first study of drugs 28 days before or 5 half-lives (whichever is shorter) had received any chemotherapy, immunotherapy (such as interleukin, interferon, thymosin peptide) or any experimental treatment of the first study of drugs within 14 days before administration; 8. Use sorafenib, regrafenib or any Chinese herbal or proprietary medicine for cancer control; 9. Patients need to use corticosteroids within 14 days prior to the study of drug administration (prednisone > 10 mg/day or equivalent dose of the same drug); 10. History of hepatic encephalopathy or liver transplantation; 11. Clinical symptoms requiring drainage of pleural effusion, ascites and pericardial effusion; 12. Any life-threatening bleeding events occurred in the past three months, including requiring blood transfusion, surgery or local treatment, continuous drug therapy; 13. Arterial and venous thromboembolism events in the past six months, including encephalopathy and pericardial effusion. It includes the history of myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. Implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except thrombosis stabilized after routine anticoagulation therapy. Allow prophylactic use of low-molecular-weight heparin (such as enoxaparin 40 mg/day); 14. uncontrollable hypertension, with systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg after optimal medical treatment, hypertension crisis or history of hypertensive encephalopathy; 15. Within two weeks before the first administration, aspirin (325 mg/day) or aspirin for 10 consecutive days or other known drugs that can inhibit platelet function, such as dipyridamole or clopidogrel; 16. Symptomatic congestive heart failure (New York Heart Association Class II-IV). Symptomatic or poorly controlled arrhythmia. congenital long QT syndrome or corrected QTc > 500ms(calculated by Fridericia method); 17. Got treatment in other clinical trials within four weeks before the first administration; 18. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of response;progress free survival;disease control rate;clinical benefit rate; | — |
Countries
China
Contacts
Public ContactYan Sheng
The Second Affiliated hospital of Zhejiang University School of Medicine
Outcome results
None listed