Cholangiocarcinoma
Conditions
Interventions
Test group:Icaritin combined with mFolfox chemotherapy
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign an informed consent form. If the subjects were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them during the informed consent process and sign the informed consent form. If the subjects were unable to read the informed consent form (e.g., illiterate subjects), witnesses were required to witness the informed consent process and sign the informed consent. 2. age >=18 years old; 3. cholangiocarcinoma confirmed by histology or cytology. 4. patients who failed first-line systemic therapy (treatment failure: disease progression or unacceptable toxicity). 5. presence of at least one measurable lesion defined by RECIST v1.1 or mRECIST. 6. expected survival time >3 months. 7. ECOG score: 0-1. 8. Eligible patients had adequate organ function: (1) Hemoglobin >=90g/ L (2) Absolute neutrophil count >=1.5×10^9/ L (3) Platelet count >=75×10^9/ L (4) Aspartate or alanine aminotransferase =60ml/min (according to the Cockcroft-Gault equation) (6) Serum total bilirubin <=1.5×ULN in patients without obstruction (7) Patients have total bilirubin <3×ULN after jaundice reduction 9. Women of childbearing potential or men whose partner is of childbearing potential are required to use highly effective contraception throughout the study.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to the ingredients in the test drug, or have metabolic disorders. 2. Severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic system diseases. 3. clinically significant heart disease, such as congestive heart failure, symptomatic coronary heart disease, drug-refractory arrhythmia, NYHA class 2 or above heart failure, and left ventricular ejection fraction (LVEF) 10000IU/ml and abnormal liver function; Untreated hepatitis C or co-infection with hepatitis B and C. 9. have participated in another clinical trial involving a study related therapeutic agent or in a concurrent interventional clinical trial within the past 3 months. 10. female patients who are pregnant or lactating, or male or female patients of childbearing age who are unwilling to use effective birth control from screening until 90 days after the last dose. 11. Vulnerable groups other than the elderly/illiterate, including people with mental illness, cognitive impairment, critically ill patients, illiterate, etc. 12. other patients who were deemed by the investigator to be unsuitable for the study, including patients who were judged by the investigator to be less able to adhere to the study procedures, restrictions, and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;progression free survival, PFS; | — |
Countries
China
Contacts
Public ContactLiang Xiao
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed