Advanced Biliary Tract Carcinoma
Conditions
Interventions
experimental group:Lenvatinib Plus PD-1 Inhibitors(Tislelizumab)
Sponsors
Sir Run Run Shaw Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. The expected survival time before treatment was more than 3 months; 3. Pathologically confirmed advanced (metastatic) and / or unresectable (locally advanced) cholangiocarcinoma (intrahepatic and extrahepatic cholangiocarcinoma and gallbladder carcinoma); 4. No previous immunotherapy history; 5. According to mRecist /Recist1.1, there is at least one measurable and evaluable lesion; 6. Child Pugh of liver function grade A , serum total bilirubin (TBIL) = 28 g / L; alkaline phosphatase (ALP) <= 5 x ULN; 7. ECOG PS<1; 8. Sign the written informed consent; 9. The patient refused chemotherapy or the researcher considered the patient could not tolerate chemotherapy; 10. The patient plans to receive targeted therapy with lenvastinib.
Exclusion criteria
Exclusion criteria: 1. Mixed hepatocellular cholangiocarcinoma; 2. Patients who have received first-line treatment such as targeted therapy, radiotherapy and chemotherapy; 3. Tumor thrombus in main portal vein or inferior vena cava; 4. Baseline laboratory parameters: hemoglobin 3 x upper limit of normal value (ULN). Ast or ALT > 5 times of upper normal limit (ULN); serum creatinine > 1.5 x ULN; creatinine clearance 2.3; ALT > 5 times of upper normal limit (ULN); 5. Local treatment of liver within 4 weeks before admission; 6. Patients with interstitial lung disease, non infectious pneumonia or uncontrolled pneumonia have a history of systemic diseases, including diabetes and hypertension; 7. Patients need to use corticosteroids (prednisone > 10 mg / day or the same dose of prednisone > 10 mg / day or the same dose of prednisone) within 14 days before the study medication; 8. Clinical symptoms of pleural effusion, ascites and pericardial effusion requiring drainage; 9. Any life-threatening bleeding events occurred in the past three months, including the need for blood transfusion, surgery or local treatment, and continuous drug treatment; 10. Arteriovenous thromboembolic events in the past 6 months, including encephalopathy and pericardial effusion. It includes a history of myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. Thrombus formation was induced by implantable vein infusion port or catheter, or superficial vein thrombosis, except for thrombus stabilization after conventional anticoagulant therapy. Prophylactic use of low molecular weight heparin (such as enoxaparin 40 mg / day) is allowed; 11. Uncontrolled hypertension, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg after the best treatment, hypertension crisis or history of hypertensive encephalopathy; 12. Take aspirin (325 mg / D) or aspirin or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, for 10 consecutive days within two weeks before the first medication; 13. Symptomatic or poorly controlled arrhythmia, congenital prolonged QT syndrome or corrected QTc>500ms (calculated according to Fridericia's method); 14. Lactating women; 15. Vulnerable groups: including mental patients, critically ill subjects, pregnant women, minors, cognitive impairment, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Disease control rate;Overall survival;Conversion surgery rate; | — |
Countries
China
Contacts
Public ContactCai Xiujun
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Outcome results
None listed