Biliary tract cancer
Conditions
Interventions
Group 2:Targeted therapy of arotinil
Group 1:optimal support care
Sponsors
Hunan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 ~ 80 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; Damage caused by other treatments was recovered (NCI-CTCAE version 4.0 grade < 1), in which the interval of receiving nitrosourea or mitomycin was more than 6 weeks; other cytotoxic drugs, apatinib, radiotherapy or surgery were more than 4 weeks; EGFR TKI molecular targeted drugs were more than 2 weeks; 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/dLTotal bilirubin < 1.5 times the upper limit of normal value (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times of ULN (liver metastasis patients need < 5 times of ULN), amylase and lipase < 1.5 times of ULN, serum urea nitrogen < 1.5 times of ULN, serum creatinine < 1.5 times of ULN, or creatinine clearance rate < 45 mL/min; 7. According to RECIST 1.1 standard, there is at least one assessable lesion; 8. No other concurrent anti-cancer therapy (including local radiotherapy, systemic chemotherapy and molecular targeted therapy); 9. Patients and/or their families know and agree to participate in the trial and sign the informed consent; 10. Women of childbearing age must have a negative pregnancy test 7 days before admission. Voluntary use of appropriate methods of contraception during the observation period and within 8 weeks after the last administration of Anlotinib; for men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of Anlotinib.
Exclusion criteria
Exclusion criteria: 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. Squamous cell carcinomas (including adenosquamous cell carcinomas), imaging (CT or MRI) showed that the distance between the lesion and the great vessels was less than 5 mm, or there were central or necrotic tumors invading the local large vessels; 7. Hypertension was poorly controlled, resting blood pressure still exceeded 140/90 mmHg under the fixed hypotension regimen, or the maximum dose of calcium channel blocker was needed to stabilize blood pressure; 8. Patients with myocardial ischemia or myocardial infarction above grade II and arrhythmias with poor control (including male (>450 ms) and female (>470 ms) during the QTc interval; 9. According to NYHA criteria, patients with grade III to IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% indicated by color Doppler echocardiography (CDFI); 10. Coagulation dysfunction (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN) is prone to bleeding or is undergoing thrombolytic or anticoagulant therapy; 11. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; 12. Massive hemorrhage (active hemorrhage or hemorrhage > 30 ml in 3 months before the test) or hemoptysis (> 50 ml blood) within 4 weeks in the group; 13. Significant clinical bleeding symptoms or definite bleeding tendency occurred within the first three months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ or above, or vasculitis; 14. Arteriovenous thrombosis events occurred within the first 12 months at random, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 15. Existing hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.); 16. Long-term unhealed wound or fracture; 17. Major surgical operations or severe traumatic injuries, fractures or ulcers were performed within the first 4 weeks at random; 18. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 19. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before randomization; 20. Urinary routine indicated that urinary protein (++) or confirmed 24-hour urinary protein (> 1.0 g); 21. Serous effusion (including pleural effusion, ascites and pericardial effusion) with clinical symptoms requiring surgical treatment; 22. Patients with active hepatitis B or C; 23. Active infections require antimicrobial treatment (e.g. antibiotics, antivirals, antifungal drugs) 24. Those who have a history of psychotropic drug abuse and are unable to give up or have mental disorders; 25. Those who participated in clinical trials of other antineoplastic drugs within the first four weeks of randomization; 26. Those who had used related target inhibitors such as VEGFR before randomiz
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective remission rate;DCR; | — |
Countries
China
Contacts
Public ContactHuaxin Duan
Hu'nan Provincial People's Hospital
Outcome results
None listed