Intrahepatic cholangiocarcinoma
Conditions
Interventions
Case series:Hepatic arterial infusion chemotherapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study, signed informed consent, and followed up; 2. Aged 18-75 years old male and female; 3. ECOG physical status score: 0-2 points; 4. Unresectable intrahepatic cholangiocarcinoma confirmed by histology and imaging (multi-focal intrahepatic disease, lymph node metastasis and distant metastasis); 5. At least one measurable lesion, spiral CT or nuclear magnetic examination with a maximum diameter of =10mm, common CT maximum diameter of =2cm; 6. Estimated survival time = 3 months; 7. Baseline blood routines and biochemical routines meet the following criteria: Absolute neutrophil count (ANC) =1.5 x 10^9/L (1500/mm3); Platelets =75 x 10^9/L; Hemoglobin =9 g/dL; Serum bilirubin = 1.5 times the upper limit of normal; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times the upper limit of normal (if ALT is allowed for liver metastasis, ALT = 5 times the upper limit of normal); Serum creatinine = 1.5 times the upper limit of normal; 8. No malabsorption or other conditions affecting treatment; 9. No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever >38 degree C; 10. Patients with good compliance are expected to complete efficacy and adverse reaction evaluation and follow-up according to the program requirements; 11. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. Men should be surgically sterilized, or consent to appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. Patients with a clear tendency to gastrointestinal bleeding, including the following conditions: local active ulcer lesions, and fecal occult blood (++); a history of melena and hematemesis within 2 months; 2. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or above coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male >450 ms, female >470 ms) and grade I cardiac insufficiency; 3. Severe postoperative complications such as intestinal obstruction, anastomotic leakage, pancreatic fistula or anastomotic stenosis; 4. Urine routine indicates that urine protein = ++ and confirmed 24-hour urine protein quantitation > 1.0 g; 5. Long-term unhealed wounds or incompletely fractured fractures; 6. Have a history of immunodeficiency, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 7. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency (must be satisfied 14 days before randomization: INR is within normal range without anticoagulant); application of anticoagulant Or a vitamin K antagonist such as warfarin, heparin or the like to treat the patient; under the premise of INR = 1.5, a small dose of warfarin (1 mg orally, once daily) or a small dose of aspirin is allowed for prophylactic purposes (per Daily dosage does not exceed 100 mg); 8. Overactive/venous thrombosis occurred within one year prior to screening, such as cerebrovascular accidents (including transient ischemic attacks) and deep vein thrombosis (except for those who have recovered from venous catheterization due to prior chemotherapy) ) and pulmonary embolism; 9. Known to be allergic to any component of the FOLFOX regimen; 10. According to the investigator, there are systemic diseases that are severe or uncontrollable (including active infections, grade IV hypertension, unstable angina, congestive heart failure, liver and kidney or metabolic diseases); 11. Patients with brain metastases, who did not receive definitive surgery and/or radiation therapy, or patients with previously diagnosed and treated brain metastases, if the clinical condition is unstable and require hormone therapy, or hormones are not needed but before the hormone The treatment interval is less than 4 weeks; 12. There is a clear history of neurological or psychiatric disorders, including epilepsy or dementia; 13. Have had other cancers in the past or at the same time; 14. Accept any other anti-tumor treatment at the same time; 15. Has participated in other clinical trials; 16. Can not cooperate with the completion of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Response rate; | — |
Countries
China
Contacts
Public ContactZhong-Guo Zhou
Sun Yat-Sen University Cancer Center
Outcome results
None listed