Intrahepatic Cholangiocarcinoma
Conditions
Interventions
Test group:Radiation therapy + targeted therapy + immunotherapy
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Age 18-75 years regardless of sex; 2 Patients with intrahepatic cholangiocarcinoma diagnosed by pathological histologic or cytologic examination; 3 Patients with resectable ICC with high risk factors for recurrence; 4 There were no distant metastases; 5 ECOG rating 0-1; 6 Child-Pugh Liver Function Score Grade A or B = 7 points; 7 Presence of at least 1 measurable lesion (RECIST v1.1 criteria); 8 If HBV antigen-positive patient, HBV DNA <500 IU/ml, conventional antiviral therapy; 9 Normal functioning of major organs; 10 Adequate control of blood pressure (BP) with up to 3 antihypertensive medications, defined at screening as BP <=150/90 millimeters of mercury (mmHg) and no change in antihypertensive therapy in the week prior to cycle/day 1; 11 Patients are expected to survive longer than 3 months; 12 Subjects voluntarily enrolled in the study and signed an informed consent form, were compliant and cooperated with follow-up visits;
Exclusion criteria
Exclusion criteria: 1 Presence of extrahepatic metastases other than regional lymph nodes; 2 Tumors with extensive involvement of the left and right lobes of the liver; 3 Patients with prior treatment with chemotherapeutic agents, targeted agents, and immune checkpoint inhibitors; 4 Hypersensitivity to lenvatinib or PD-1 inhibitor components; 5 Have class II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; 6 Abnormal coagulation (INR >1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 × ULN), bleeding tendency or on thrombolytic or anticoagulant therapy; 7 Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to use effective contraception; 8 Mental illness, or history of psychiatric substance abuse; 9 Combined HIV-infected patients; 10 History of hepatic resection, liver transplantation, history of interventional therapy with other malignancies (except adequately treated basal cell carcinoma of the skin or squamous cell skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma); 11 Patients with active infection (HBV DNA = 104 copies/ml, HCV RNA = 1000 after antiviral treatment can be considered for inclusion); 12 patient with a contraindication to radiotherapy; 13 Participation in a clinical trial of another experimental drug or device within four weeks.; 14 The researcher did not consider it appropriate to enroll;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year relapse-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective mitigation rate;safety; | — |
Countries
China
Contacts
Public ContactGong Li
Beijing Tsinghua Changgung Hospital
Outcome results
None listed