Intrahepatic Cholangiocarcinoma
Conditions
Interventions
Treatment of Unresectable or Metastatic Intrahepatic Cholangiocarcinoma:hepatic arterial infusion chemo- therapy
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The research participant has voluntarily signed the informed consent form; 2.Age 18-75 years, inclusive; any gender; 3.Pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma (Stage IIIB-IV); 4.At least one measurable lesion as defined by RECIST v1.1 criteria; 5.No prior systemic anti-tumor therapy, or has received neoadjuvant/adjuvant chemotherapy with disease progression or recurrence occurring more than 6 months after the completion of therapy; 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; 7.Adequate organ function, defined as: (1) Bone marrow function: Hemoglobin >= 9.0 g/dL; Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L; Platelets >= 100 × 10^9/L; (2) Liver function: Serum total bilirubin = 50 mL/min as calculated by the Cockcroft-Gault formula; (4) Cardiac function: New York Heart Association (NYHA) functional classification = 50%; 8.Estimated life expectancy of >= 3 months; 9.Women of childbearing potential (WOCBP) must use a reliable method of contraception, have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and agree to use an adequate method of contraception during the study and for 6 months after the last dose of the investigational drug. Men must agree to use an adequate method of contraception during the study and for 6 months after the last dose of the investigational drug; 10.The participant is willing to join the study, has signed the informed consent form, and is expected to have good compliance and be cooperative with follow-up procedures;
Exclusion criteria
Exclusion criteria: 1.Known allergy or hypersensitivity to any of the investigational drugs or their excipients, or a history of severe hypersensitivity reactions, or any contraindications to the study drugs; 2.History of poorly controlled cardiovascular or cerebrovascular events, such as: (1). Heart failure of NYHA Class >= III; (2). Unstable angina; (3). Myocardial infarction within the past year; (4). Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5). Cerebral hemorrhage or cerebral infarction (except for asymptomatic lacunar infarcts not requiring treatment); (6). History of a severe cardiovascular or cerebrovascular event within the past 12 months; (7). Uncontrolled hypertension, defined as systolic pressure >140 mmHg or diastolic pressure >90 mmHg despite single-agent therapy; (8). History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, or evidence/history of bleeding tendency within 2 months prior to enrollment, regardless of severity. (9). Stroke or transient ischemic attack (TIA) within 12 months prior to enrollment. 3.History of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung disease, or other poorly controlled systemic diseases (including but not limited to diabetes, hypertension); 4.History of active immunodeficiency or autoimmune disease, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or autoimmune disease; 5.Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis. Patients with a history of active tuberculosis infection =1 year prior to screening are also excluded, unless documentation of completed appropriate treatment can be provided; 6.Presence of brain or leptomeningeal metastases; 7.Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 2 weeks prior to the first administration of the study drug; 8.Presence of a clinically detectable second primary malignancy at enrollment, or any other malignancy within the last 5 years (with the exception of adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ); 9.Any major surgery within <=28 days prior to the first administration of the study drug; 10.Prior allogeneic stem cell transplantation or solid organ transplantation; 11.Current gastrointestinal conditions such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions judged by the investigator to potentially cause GI bleeding or perforation; or a history of intestinal perforation or fistula that has not fully healed after surgery; 12.Receipt of a live vaccine within 4 weeks (inclusive) prior to the first dose of the study drug. Seasonal influenza vaccines, which are generally inactivated, are permitted; intranasal vaccines, which are live attenuated, are not permitted; 13.Any other factors that, in the judgment of the investigator, may lead to the premature discontinuation of the study, such as other serious diseases (including psychological or psychiatric disorders) requiring concomitant therapy, significant laboratory abnormalities, or family/social factors that could compromise the participant's safety or the collection of data and samples; 14.Current participation in an interventional clinical trial, or receipt of other investigational drugs or use of an in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Adverse event incidence;Duration of Response (DOR);Progression-Free Survival (PFS);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactZhang Zongli
Qilu Hospital of Shandong University
Outcome results
None listed