Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group 1:After radical resection of intrahepatic cholangiocarcinoma, S1 was given orally, 40mg/ time, twice/day x 14 days, rest for 7 days, maintenance for 3 months, routine follow-up
Experimental group 2:After radical resection of intrahepatic cholangiocarcinoma, patients were given 1 tablet (10mg) of retinoic acid, 3 times A day, in addition to S1 orally, for 3 months, regular fo
Sponsors
Eastern Hepatobiliary Surgical Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients volunteered for the study and signed an informed consent form; 2. Aged over 18 years, any gender; 3. The primary hepatic tumor was resected and proved to be cholangiocarcinoma; 4. Liver function, Child A; 5. Ability to swallow pills normally, ECOG score 0-1; 6. Expected Life Span >=12 weeks; 7. Important organ function is combined with the following requirements: (1)Hemoglobin >=90g/L; (2)Neutrophil count >=1.5x10^9/L; (3)Platelet count >=60x10^9/L; (4)Alb Bilirubin >=30g/L; (5)Total Bilirubin <=1.5xULN(7 days before the first medication); (6)ALT and AST <=3xULN(7 days before the First Medication); (7)AKP <=2.5xULN; (8)Serum Creatinine <=1.5xULN; 8. Status of Hepatitis B infection: HBV-DNA<1000 copies/ml, or hbv-dna & GT; 1000 COPIESML, start oral antiviral drug at least 1 week before starting chemotherapy; 9. Non-surgical sterilization or women of childbearing age were required to use a medically approved contraceptive measure (such as Intrauterine device, birth control pills or condoms) during the study period and within 3 months after treatment; non-surgical Sterilization Women of childbearing age were required to have a negative serum or urine HCG test within 72 hours prior to enrollment in the study group; and they were required to be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to experimental drug ingredients; 2. Patients who had previously received radiation therapy, TACE, and hormone therapy were studied less than 4 weeks after completion of treatment (the last dose); There are clinical symptoms or diseases of heart that can not be well controlled: (1) Heart failure above Grade 2, unstable angina; (2) Myocardial Infarction within 1 year; (3) Clinically significant supraventricular or ventricular Arrhythmia requiring treatment or intervention; 4. There were significant clinical bleeding symptoms or definite bleeding tendency in the first 3 months, such as gastrointestinal bleeding, bleeding esophageal Gastric varices, bleeding gastric ulcer or vasculitis, at baseline, if stool occult blood was positive, reexamination was needed, if no negative change was found, gastroscopy and colonoscopy were needed, if gastroscopy revealed severe Gastric varices with red sign, the patients could not be enrolled; 5. Known genetic or acquired bleeding and thrombotic tendencies; 6. Urine routine indicated urinary Protein >= + + and confirmed 24-hour Urinary Protein Volume >1.0g; 7. Patients with active infection had fever of unknown origin >=38.5 °C or White Blood Cell Count >=15x10^9/L at Baseline within 7 days before administration; 8. Infection with HCV, HIV or syphilis; 9. The patient has had other malignancies within 3 years or at the same time; 10. Patients with chronic headache or migraine that can not be relieved by medication; 11. The researchers concluded that other factors, such as severe mental illness, Substance Abuse, family or social factors, were not appropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactShi Jie
Eastern Hepatobiliary Surgical Hospital
Outcome results
None listed