Biliary tract cancers
Conditions
Interventions
Experimental group:Anlotinib Hydrochloride + Sintilimab
Sponsors
Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before any trial-related procedures are implemented; 2. Male or female aged 18 to 75 years; 3. Locally advanced or metastatic biliary tract tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer) confirmed by histology or cytology and unresectable; 4. No systemic chemotherapy, molecular targeted drug therapy and immunotherapy; 5. Expected survival time > 3 months; 6. At least one measurable lesion according to RECIST1.1 criteria; 7. ECOG?PS score is 0-1; 8. Sufficient organ function, subjects should meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) is >=1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets >= 90 x 10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin > 9g/dL without blood transfusion or use of erythropoietin in the past 14 days; (4) Total bilirubin = 60ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) The myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that the simple laboratory abnormality does not have clinical significance, it is also allowed to enter the group). 9. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age were defined as having been postmenopausal for at least 1 year, or had undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases outside the biliary tract within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Ampullary tumor; 3. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 4. Patients who have previously received VEGFR target inhibitor drugs including Anlotinib hydrochloride capsules, or have used other PD-1/PD-L1/CTLA-4 antibody therapy or other anti-PD-1/PD therapy - Immunotherapy of L1/CTLA-4; 5. Received palliative radiotherapy for biliary tract tumors in the past, except for postoperative adjuvant radiotherapy. 6. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration; 7. Active autoimmune disease requiring systemic therapy (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years prior to the first dose. Replacement therapy (eg, thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy. Known history of primary immunodeficiency. Only patients with positive autoimmune antibodies need to confirm whether there is an autoimmune disease according to the judgment of the investigator; 8. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks before the first dose of the study Note: The use of physiological doses of Glucocorticoids (<=10 mg/day prednisone or equivalent); 9. There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not require drainage of effusion or who have no significant increase in effusion after stopping drainage for 3 days can be enrolled); 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Known allergy to the active ingredients or excipients of the study drug sintilimab; 12. Have not recovered sufficiently from toxicity and/or complications caused by any intervention (ie, <= grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiation of therapy; 13. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 14. Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of the normal value of the laboratory department of the research center), Note: Hepatitis B subjects who meet the following criteria can also be included in the group: (1) HBV viral load <2.5x103 copies/ml (500IU/ml) before the first dose, subjects should receive anti-HBV therapy throughout the study treatment period; (2) For subjects with anti-HBc(+), HBsAg(-), anti-HBs(-) and HBV viral load(-), prophylactic anti-HBV treatment is not required, but viral reactivation needs to be closely monitored; 15. Active HCV-infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 16. Inoculated with live attenuated vac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;sustained remission rate;progression-free survival;Adverse reactions;overall survival; | — |
Countries
China
Contacts
Public ContactChen Zushun
Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed