Biliary tract cancer
Conditions
Interventions
Apatinib group / optimal supportive therapy:Aptinib versus supportive therapy
Sponsors
Hunan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Main Inclusion criteria: 1. Aged 18 ~ 85 years old; 2. Diagnosed as unresectable, recurrent or metastatic gallbladder carcinoma and cholangiocarcinoma (including intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma)) by histopathology or cytology; 3. Patients are not tolerant or unwilling to receive chemotherapy regimens; 4. The Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and life expectancy = 3 months; 5. Blood routine: hemoglobin = 10 g / dL; white blood cell count (WBC) = 3.0*10^9/L; neutrophil count = 1.5*10^9/L; platelet count = 80*10^9/L; 6. Blood biochemistry:serum albumin = 2.8 g/dL; total bilirubin =1.5 times the upper limit of normal (ULN) (except in patients with Gilbert syndrome); alanine aminotransferase (ALT) and aspartate (AST) = 2.5 times ULUL (liver metastases =5 times ULN); amylase and lipase = 1.5 times ULN; serum urea nitrogen <1.5 times ULN, serum creatinine <ULN 1.5 Times, or creatinine clearance rate = 45mL / min; 7. With reference to the RECIST 1.1 standard, there is at least one assessable lesion; 8. No other anti-cancer treatment (including local radiotherapy, systemic chemotherapy and molecular targeted therapy) at the same time; 9. The patient and/or family members shall be informed and agree to participate in this test and sign the informed consent form; 10. Women of childbearing age must undergo pregnancy test negative 7 days before enrollment. The appropriate method of contraception was adopted during the observation period and the last eight weeks after the apatinib. For men, surgical sterilization should be performed, or agree to use appropriate methods of contraception within 8 weeks after the last eight weeks after the apatinib and during the whole observation period.
Exclusion criteria
Exclusion criteria: Main exclusion criteria: Patients who meet any of the following criteria will be excluded from this test: 1. With serious and uncontrolled infection; 2. Pregnant or lactating women; 3. Serious or uncontrollable systemic diseases (such as unstable or decompensated heart, liver or kidney disease); 4. Untreated unstable brain or meningeal metastasis; 5. There is a second tumor evidence in 5 years (except for non-metastatic skin basal cell carcinoma or skin squamous carcinoma or in situ carcinoma of other sites); 6. Massive bleeding (active bleeding or bleeding> 30 ml in the first 3 months of the trial) or hemoptysis (> 5 ml of blood) within 4 weeks of randomization; 7. Active intestinal perforation and intestinal obstruction; 8. Being treated with anticoagulant or thrombolytic drugs; 9. The control of hypertension is poor, and the resting blood pressure is still more than 150/100mmhg under the fixed step-down scheme, or the maximum dose of calcium channel blocker is required to stabilize blood pressure. 10. Proteinuria was two consecutive greater than + 1 (24 h urine protein less than 1.5 g or protein creatinine ratio less than 1.5 except) 11.ECG QT more than 480ms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactHuaxin Duan
Hu'nan Provincial People's Hospital
Outcome results
None listed