Cholangiocarcinoma
Conditions
Interventions
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, no gender limit; 2. ECOG stamina score: 0-2 points; 3. Diagnosed as cholangiocarcinoma by histopathology; 4. Recurrent or metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer) 5. Definition of patients with recurrent or metastatic cholangiocarcinoma who failed the first-line treatment: (1) Disease progression after treatment with first-line gemcitabine-containing drugs; (2) Recurrence or progression of the disease during adjuvant/neoadjuvant therapy containing gemcitabine or fluorouracil drugs or within = 10mm, and the maximum diameter of ordinary CT is >= 2cm; 7. Have not received apatinib or other anti-angiogenesis drugs in the past, such as sorafenib, sunitinib, bevacizumab, endu, etc.; 8. Estimated survival time> 3 months; 9. Hemoglobin (HB) >= 80 g/L (no blood transfusion within 14 days); white blood cell count (WBC) >= 3x10^9 /L; neutrophil (ANC) >= 1.5x10^9 /L; platelet calculation (PLT) >= 100x10^9 /L; 10. Total bilirubin (TBIL) = 60mL/min; 12. Urine routine prompts urine protein 24-hour urine protein quantitative < 1.0 g; 13. Blood pressure is normal or under control; 14. The subjects voluntarily signed the informed consent form, and they have good compliance and cooperate with the follow-up..
Exclusion criteria
Exclusion criteria: 1. Patients with a clear gastrointestinal bleeding tendency, including the following conditions: local active ulcer lesions and fecal occult blood (+ +); patients with a history of melena and hemorrhage within 2 months; 2. Combined with serious postoperative complications such as intestinal obstruction, anastomotic fistula, pancreatic fistula or anastomotic stenosis; 3. Long-term unhealed wounds or fractures with incomplete healing; 4. Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 5. Abnormal blood coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency (14 days before randomization must meet: INR is within the normal range without anticoagulant); use anticoagulant Or vitamin K antagonists such as warfarin, heparin or its analogues to treat patients; under the premise of INR <= 1.5, it is allowed to use low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (per Daily dosage does not exceed 100 mg); 6. Arteriovenous thrombosis events occurred within one year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been cured by the investigator's judgment) And pulmonary embolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactYang Qiong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed