Intrahepatic Cholangiocarcinoma
Conditions
Sponsors
The Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Qualified participants for this study must meet all of the following criteria: 1. Sign written informed consent before implementing any testing related processes 2. Male or female = 18 years old, = 70 years old 3. Confirmed by histology or cytology as intrahepatic cholangiocarcinoma, unable to undergo surgical resection 4. Molecular typing: molecular detection of relevant targets: FGFR2, IDH1/2, HER-2, KRAS, TP53, PD-L1, selecting ICC patients with TP53 mutations 5. ICC patients with progression after first-line standard chemotherapy 6. Expected survival time>3 months 7. At least 1 measurable lesion according to RECIST 1.1 standard 8. Karnofsky Functional Status Score (KPS) score = 60 points 9. Sufficient organ function is required for the subject to meet the following laboratory indicators: 1) The absolute value of neutrophils (ANC) = 1.5x109/L without the use of granulocyte colony-stimulating factor in recent 14 days; 2) Platelets = 90 without blood transfusion in the past 21 days × 109/L; 3) In the absence of blood transfusion or use of erythropoietin in the past 21 days, hemoglobin>9g/dL; 4) Total bilirubin = 3 × Upper limit of normal value (ULN); 5) Aspartate transaminase (AST), alanine transaminase (ALT) = 2.5 × ULN (ALT or AST = 5 allowed for patients with liver metastasis) × ULN); 6) Alkaline phosphatase (AKP) = 2.5 × ULN 7) Creatinine clearance rate (calculated using the Cockcroft Fault formula) = 50 ml/min; 8) Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; 9) Normal thyroid function, defined as thyroid hormone (TSH = 10) within the normal range; If there is no clinically significant thyroid dysfunction after thyroid hormone supplementation, they can also be included in the group. 10) The myocardial enzyme spectrum is within the normal range (if the researcher comprehensively determines that a simple laboratory abnormality without clinical significance is also allowed to be included); 10. For female subjects of childbearing age, they should undergo a urine or serum pregnancy test with a negative result within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non reproductive age are defined as those who have undergone at least one year of menopause or have undergone surgical sterilization or hysterectomy 11. If there is a risk of conception, all participants (whether male or female) are required to sign written informed consent for the use of contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period and up to 120 days after the last study drug administration. Prior to the implementation of any trial related procedures, written informed consent is required 12. Willing to accept this treatment plan
Exclusion criteria
Exclusion criteria: The subjects cannot have any of the following exclusion criteria: 1. Diagnosed as other malignant diseases outside the biliary tract within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ carcinoma after radical resection, and thyroid papillary carcinoma can also be included after radical surgery); 2. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 3. Active autoimmune diseases that require systemic treatment (such as the use of disease relieving drugs, glucocorticoids, or immunosuppressants) have occurred before the first administration. Alternative therapy (such as thyroxine, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) is not considered systemic treatment. A known history of primary immunodeficiency. Patients with only positive autoimmune antibodies need to confirm the presence of autoimmune diseases based on the judgment of researchers; 4. Individuals who are known to be allergic to the investigational drug Xindilizumab and arsenic trioxide components or excipients in this study 5. Not fully recovered from toxicity and/or complications caused by any intervention measures before starting treatment (i.e. = level 1 or reaching baseline, excluding fatigue or hair loss) 6. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive) 7. Except for COVID-19 vaccine, which has been inoculated with live attenuated vaccine within 4 weeks before the first administration 8. Pregnant or lactating women 9. There are any serious or uncontrollable systemic diseases, such as: 1) There are serious and uncontrollable abnormalities in rhythm, conduction or morphology of resting ECG, such as completeness left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina, congestive heart failure, chronic heart failure with a New York Heart Association (NYHA) rating of = 2; 3) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the treatment; 4) Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures have been performed within 4 weeks prior to the first administration. Received tissue biopsy or other minor surgical procedures within 7 days prior to the first administration, except for venous catheterization for the purpose of intravenous infusion 5) Poor blood pressure control (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 6) Active pulmonary tuberculosis; 7) There are active or uncontrollable infections that require systemic treatment; 8) Presence of clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction; 9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) Poor control of diabetes (FBG>10mmol/L); 11) Urinary routine examination indicates that urine protein is =++, and it is confirmed that 24-hour urine protein quantification is greater than 1.0g; 12) Patients with mental disorders who are unable to cooperate with treatment; 10. Medical history or evidence of illness, abnormal treatment or laboratory test values that may interfe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate ;progression-free survival ;overall survival ;Quality of life;safety and tolerability ; | — |
Countries
China
Contacts
Public ContactWan Xuying
The Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital)
Outcome results
None listed