Cholangiocarcinoma
Conditions
Interventions
case series:Nil
Sponsors
The Fifth Center of General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years(inclusive), male or female; 2. Unresectable or distant metastatic cholangiocarcinoma diagnosed by histopathological examination; 3. With >= 1 measurable lesions; requirements: the selected target lesions have not received local treatment before, or the selected target lesions are located in the area of ??previous local treatment, and are later determined to be disease progression (PD) by imaging assessment; 4. Child-Pugh liver function classification is A or B; 5. ECOG (Eastern Cooperative Oncology Group) Physical Status Score (PS) of 0 or 1; 6. The function of major organs meets the following requirements: absolute neutrophil count >= 1.5x10^9/L; platelet count >= 50x10^9/L; hemoglobin >= 90 g/L; serum albumin >= 28 g/L; serum albumin >= 28 g/L; Total bilirubin = 40 mL/min (calculated by Cockcroft-Gault formula). International normalized ratio (INR) <= 2 or prothrombin time (PT) exceeding the upper limit of the normal range <= 6 seconds; 7. Antiplatelet or anticoagulant therapy such as aspirin, clopidogrel, dipyridamole, ticlopidine or cilostazol should be discontinued 7 days before receiving local infusion chemotherapy; 8. Female patients of childbearing age must undergo a blood pregnancy test within 7 days before enrollment, and the result is negative, and agree to use a reliable and effective method of contraception during the test and within 60 days after the last administration of the test drug. Breastfeeding is not allowed during the medication, and male patients whose partners are women of childbearing age must agree to use reliable and effective contraception during the trial and within 12 months after the last administration of the trial drug; 9. Patients participate voluntarily, give full informed consent, sign a written informed consent form, and have good compliance; or be exempted from informed consent with the approval of the ethics committee; 10. The expected survival period is greater than 12 weeks.
Exclusion criteria
Exclusion criteria: Malignant tumors other than cholangiocarcinoma within 1.5 years; except for limited tumors cured by research, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, etc.; 2. Received surgery within 4 weeks before enrollment; received palliative radiotherapy for bone metastases within 2 weeks prior to enrollment; toxic reactions (except hair loss) caused by previous treatment did not recover to = grade 3 (reference standard: CTCAE v5.0) gastrointestinal fistula or non-gastrointestinal fistula; 5. Previous history of serious cardiovascular and cerebrovascular diseases: New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina pectoris, myocardial infarction or cerebrovascular accident within 12 months before enrollment, or Poorly controlled arrhythmia; echocardiography examination LVEF (left ventricular ejection fraction) 480ms (calculated by Fridericia method, if QTc is abnormal, it can be detected 3 times continuously at 2 minutes interval, Medication-resistant hypertension (systolic blood pressure (BP) >=150 mmHg and/or diastolic blood pressure >=100 mmHg) (based on the average of >=3 BP readings obtained from >=2 measurements); previous occurrence Hypertensive crisis or hypertensive encephalopathy; 6. Received medium and large surgical treatment within 4 weeks before enrollment, excluding diagnostic biopsy; 7. Existing central nervous system transfer; 8. Suffering from severe unhealed wounds, active ulcers and untreated fractures; 9. Active autoimmune disease requiring systemic therapy within the past 2 years (ie, immunomodulatory drugs, corticosteroids, or immunosuppressive drugs); Physiological corticosteroid replacement therapy for functional insufficiency) is not considered systemic therapy, and its use and enrollment are permitted; 10. A history of definite interstitial lung disease or non-infectious pneumonia, unless caused by local radiotherapy; known active tuberculosis, or received anti-tuberculosis treatment within 1 year before enrollment; 11. Any serious acute or chronic infection that requires systemic antibacterial, antifungal or antiviral treatment at the time of screening, excluding viral hepatitis; 12. Known history of human immunodeficiency virus (HIV) infection; 13. Previously received allogeneic stem cell or solid organ transplantation; 14. Known to have severe allergies to any drugs or reagents that may be involved in the treatment; 15. Patients with severe mental problems, cognitive dysfunction, and intellectual impairment; 16. Others deemed inappropriate by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactLu Yinying
The Fifth Center of General Hospital of the People's Liberation Army
Outcome results
None listed