Intrahepatic Cholangiocarcinoma
Conditions
Interventions
Case series:SHR-1210+apatinib
Sponsors
Third Affiliated Hospital of the Second Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. unresectable or recurrent advanced Intrahepatic cholangiocellular carcinoma (cannot be PVTT patients); 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; 4. Expected survival >=12 weeks; 5. Swallowing tablets normally; 6. All patients need to provide tumor tissue specimens (fresh tissue specimens or paraffin specimens) for PD-L1 expression analysis; 7. At least one measurable lesion without local treatment according RECIST 1.1 criteria; 8. The following laboratory parameters: (1) Absolute neutrophil count (ANC) >=1.5x10^9/L, Platelet count (PLT)>=100x10^9/L, Hemoglobin (HB)>=9g/dL(No blood transfusion or component blood was received within 14 days prior to the test); (2) TBIL =50 ml/min (Cockcroft-Gault formula); Child-Pugh A; (4) INR, aPTT 1+, need to collect 24-hour urinary protein measurement and the total amount should be no more than 1 gram; FT3FT4TSH should be normal or abnormal without clinical significance; (7) Normal heart function, electrocardiogram should be normal or abnormal without clinical significance, and echocardiography showed LVEF>50%; 9. The results of the serum pregnancy test in women of childbearing age must be negative within 7 days before the first use of the experimental drug; Men who are fertile or women who are likely to become pregnant must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, sexual abstinence or barrier contraception combined with spermicide) throughout the trial and continue to use contraception for 12 months after treatment; 10. Subjects voluntarily participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects had received anti PD-1, anti PD-2 or VEGFR TKI therapy; 2. The subjects had a central nervous system metastases of clinical symptoms; 3. Other clinical trials of drugs were used within 4 weeks prior to the first administration; 4. Major surgery was performed within 4 weeks prior to first administration and recovered from the side effects of the surgery, and vaccination against, immunotherapy. Radiotherapy was given within two weeks; 5. With any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and hypothyroidism and requires intermittent use of bronchodilators. Subjects with hypothyroidism, which requires only hormone replacement therapy, and skin conditions that require no systemic treatment (such as vitiligo, psoriasis, or hair loss) were eligible; 6. Subjects using immunosuppressive drugs or have received immunosuppressive drugs within 2 weeks (at most 10mg/d metacortandracin or equivalent doses of other glucocorticoids); 7. Subjects with other malignant tumour in past 5 years, except for cured basal-cell carcinoma, squamous cell carcinoma, prostate adenocarcinoma, cervical cancer in situ; 8. Subjects with hematopoietic stimulating factors, such as G-CSF and erythropoietin within 1 week before test; 9. The results of HIV antibodies or treponema pallidum antibodies showed positive; 10. Have allergic to recombinant humanized PD-1 monoclonal antibody and its components. Have allergic to apatinib and its accessories; 11. Pleural effusion or ascites with clinical symptoms and need symptomatic treatment; 12. Have history of active pulmonary disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active pulmonary tuberculosis; 13. Having any uncontrolled clinical problems, including but not limited to: (1) Persistent or active (severe) infection; (2) Hypertension with poor drug control (blood pressure continuously greater than 150/90mmHg); (3) Uncontrolled diabetes; (4) Heart disease (Class III/IV congestive heart failure or heart block, as defined by the New York Heart Association); (5) Have history of autoimmune diseases or need to receive steroids/animmunosuppressant: Hypophysitis, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc. (6) The following symptoms occurred 6 months before the test: deep vein blood clots or pulmonary embolism, myocardial infarction, severe or unstable arrhythmia or angina, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting, cerebral episode, transient ischemic attacks, cerebral embolism; 14. Any conditions that affect the subject's ingestion of medication, and any conditions that affect the process of drug disposal in the body(Absorption, distribution, metabolism, or excretion), including any type of gastroenterectomy or surgical history; 15. Coagulant function abnormality(INR>2.0, PT>16s), and have a tendency to bleed or receiving thrombolytic or anticoagulant therapy, and prophylactic use of low-dose aspirin and low molecular weight heparin is permitted; 16. There were clinically significant bleeding symptoms or definite bleeding tendency in the first 3 months, such as cough/hemoptysis 2.5ml or above, gastrointestinal bleeding, esophageal and gastric varicose veins at risk of bleeding, hemorrhagic gastric ulcer or vasculitis and so on. I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS,DoR, DCR, OS; | — |
Countries
China
Contacts
Public ContactKui Wang
Third Affiliated Hospital of the Second Military Medical University
Outcome results
None listed