Hepatobiliary Cancers
Conditions
Interventions
Single arm:Anlotinib plus PD-1 antibody
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: >= 18 years old, both male and female; 2. Patients with locally advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma / extrahepatic cholangiocarcinoma and gallbladder carcinoma); 3. Patients who failed first-line chemotherapy or were unwilling to receive first-line chemotherapy; 4. Patients with at least one measurable lesion after treatment (conforming to the requirements of resist version 1.1); 5. The function of the main organs is normal and meets the following requirements: Blood routine examination should be consistent with (no blood transfusion within 14 days) (1) HB >= 90g/L; (2) ANC >= 1.5 x 10^9/L; (3) PLT >= 80 x 10^9/L. Biochemical examination should meet the following standards: (1) TBIL = 60ml / min (Cockcroft Gault formula). 6. ECoG PS: 0-2 points of patients; 7. Patients with an expected survival time of more than 3 months; 8. The patients with good cardiac function had no myocardial infarction within half a year, and hypertension and other coronary heart disease were under control; 9. Patients without other uncontrollable benign diseases, such as lung, kidney, liver infection, etc; 10. Women of childbearing age must have negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and within 6 months after the last administration; for men, it should be surgical sterilization, or agree to use appropriate contraceptive methods during the observation period and 6 months after the last administration; 11. The subjects voluntarily joined the study and signed the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients who have used vegfr-tki small molecule drugs within 6 months, such as those treated with vandetanib, carbazotinib, renvatinib, sunitinib and sorafenib, and those who have received any antibody / drug (including PD-1, PD-L1, CTLA4, tim3 and Lag3) targeting T cell co regulatory proteins (Immune checkpoint). 2. Patients who have been proved to be allergic to the studied drug and / or its excipients; 3. Patients with multiple factors affecting oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. Patients with hypertension who cannot be reduced to normal range after antihypertensive drug treatment; 5. Patients with other serious diseases that are difficult to control (including atrial fibrillation, angina pectoris, heart failure, ejection fraction less than 50%, renal insufficiency, urinary protein more than 2 +), etc; 6. Subjects with a risk of gastrointestinal bleeding were excluded from the study, including the following conditions: (1) There were active lesions of peptic ulcer and occult blood (+ +) in stool; (2) Patients with history of melena and hematemesis within 3 months; 7. Patients with abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN), with bleeding tendency; 8. Pregnant or lactating women; 9. Patients who received live vaccination within 28 days before treatment. 10. Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or have such risks (such as receiving immunosuppressive therapy after organ transplantation). However, subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin diseases without systemic treatment (such as vitiligo, psoriasis, or alopecia) were allowed to be further screened, or they were not expected to relapse without external triggers. 11. Patients diagnosed with immunodeficiency or receiving systemic hormone therapy within 14 days prior to treatment (e.g., hormone therapy equivalent to more than 10 mg prednisone per day) or any other form of immunosuppressive therapy. Note: if the subject is not suffering from active autoimmune disease, hormone equivalent to prednisone <= 10 mg per day is allowed as adrenal replacement therapy. Subjects were allowed to use topical, ophthalmic, intra articular, nasal and inhaled corticosteroids (systemic absorption was very low). Short term use of glucocorticoids is permitted for the prevention (e.g. for contrast media allergy) or for the treatment of non autoimmune diseases (e.g. delayed hypersensitivity due to contrast media allergy). 12. Patients with active chronic hepatitis B or active hepatitis C. Subjects with positive HBsAg or HCV antibody in the screening period must undergo further quantitative detection of hepatitis B virus (HBV) DNA (excluding more than 2500 copies [CPS] / ml or 500 IU / ml) and HCV RNA detection (excluding exceeding the detection limit of the assay) can only be included in the trial after the active hepatitis B or hepatitis C infection requiring treatment is excluded. Hepatitis B virus carriers, patients with stable hepatitis B after drug treatment (DNA titer should not be higher than 2500 copies [CPS] / ml or 500 IU / ml) and patients with cured hepatitis C can be enrolled. 13. Patients with active infections requiring systematic treatment 14 d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Object Response Rate;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactBaorui Liu, Jie Shen
Cancer Center of Gulou Hospital Affiliated to Medical College of Nanjing University
Outcome results
None listed