Cholangiocarcinoma
Conditions
Interventions
trial group:Karellizumab in Combination with Apatinib
Sponsors
Hunan Provincinal People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years. 2. Patients with histopathologically or cytologically confirmed unresectable, recurrent or metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, portal cholangiocarcinoma and extrahepatic cholangiocarcinoma). 3. Patients are intolerant or unwilling to accept chemotherapy regimens. 4. An Eastern Cooperative Oncology Group (ECOG) score of 0-1 and a life expectancy of >= 3 months. 5. Routine blood count: hemoglobin >= 10 g/dL; WBC >= 3.0 x 10^9/L; neutrophil count >= 1.5 x 10^9/L; platelet count >= 80x 10^9/L. 6. Blood biochemistry: serum albumin >= 2.8 g/dL; total bilirubin = 45 mL/min. 7. The presence of at least one assessable lesion, by reference to RECIST 1.1. 8. No other concurrent anti-cancer treatment (including local radiotherapy, systemic chemotherapy and molecularly targeted therapy, etc.). 9. Patients and/or family members are expected to understand and agree to participate in the trial and sign an informed consent form. 10. Women of childbearing potential must have a negative pregnancy test 7 days prior to enrollment. Voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last administration of Camelizumab and Apatinib; in men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last administration of Camrelizumab/Apatinib tablets.
Exclusion criteria
Exclusion criteria: 1. Combined severe and uncontrollable infection; 2. Women who are pregnant or lactating; 3. Persistent severe or uncontrollable systemic disease (e.g., unstable or decompensated heart, liver, or kidney disease); 4. Untreated unstable brain or meningeal metastases; 5. Evidence of a second tumor within the last 5 years (except non-metastatic basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ elsewhere); 6. Massive bleeding (active bleeding or bleeding > 30 ml that occurred within 3 months prior to enrollment) or hemoptysis (>5 ml of fresh blood) within 4 weeks of randomization; 7. Active bowel perforation or intestinal obstruction; 8. Poorly controlled hypertension, with resting blood pressure exceeding 150/100 mmHg despite a fixed antihypertensive regimen or requiring maximum doses of calcium channel blockers to stabilize blood pressure; 9. Proteinuria for two consecutive Greater than + 1 (except 24 h urine protein less than 1.5 g or protein creatinine ratio less than 1.5); 10. ECG QT greater than 480 ms.11. Subjects with any active autoimmune disease or history of autoimmune disease. 12. known or suspected hypersensitivity to Camelizumab or Apatinib drugs. 13. untreated unstable brain or meningeal metastases. 14. history of immunodeficiency, including human immunodeficiency virus positivity, other acquired or congenital immunodeficiency disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months of overall survival; | — |
Countries
China
Contacts
Public ContactHuaxin Duan
Hunan Provincial People's Hospital
Outcome results
None listed