Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Donafenib Tosylate Tablets Combined with Sintilimab and AG Regimen
Sponsors
Subei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the group and sign a written informed consent; 2. Aged 18-75 years (including the threshold value), no gender limit; 3. Patients with intrahepatic cholangiocarcinoma diagnosed by histopathology/cytology and unresectable in stages II to III (according to the eighth edition of UICC/AJCC TNM staging system); 4. Have not received systemic treatment and tumor-related surgical treatment before (bile duct drainage is allowed); 5. Child-Pugh score 3 months; 7. At least 1 measurable lesion according to RECIST 1.1 criteria; 8. ECOG PS score is 0-1; 9. Sufficient organ function; 10. The absolute value of neutrophils (ANC) is greater than or equal to 1.5 x 10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; 11. Platelets >= 75 x 10^9/L without blood transfusion in the past 14 days; 12. Hemoglobin > 90g/dL without blood transfusion or using erythropoietin in the past 14 days; 13. Total bilirubin = 60 ml/min; 16. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) = 28g/L; 18. Myocardial enzyme spectrum is within the normal range (if the investigator comprehensively judges that the simple laboratory abnormality does not have clinical significance, it is also allowed to enter the group); 19. For female patients of childbearing potential, 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 are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 20. If there is a risk of conception, all patients (whether male or female) are required to use traceable 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 radically treated skin basal cell carcinoma, skin squamous epithelial carcinoma, and/or radically resected carcinoma in situ); 2. Malignant elements other than cholangiocarcinoma diagnosed as hepatocellular carcinoma, mixed cell carcinoma or fibrolamellar cell carcinoma; 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. Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); 5. Previous therapy with anti-PD-1, anti-PD-L1, or another drug that stimulates or synergistically inhibits T-cell receptors (eg, CTLA-4, OX-40, CD137); 6. Received targeted drug therapy in the past; 7. 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 for pleural effusion control) within 2 weeks before the first administration; 8. Active autoimmune disease requiring systemic therapy (eg, use of disease-modifying drugs, glucocorticoids, or immunosuppressants) 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; 9. 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: Physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent) are allowed; 10. Obstructive jaundice (active treatment such as biliary stent, can be enrolled after recovery of liver function); 11. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. Those who are known to be allergic to the anti-PD-1 monoclonal antibody, active ingredients or excipients of the study drug; 13. Have not recovered sufficiently from toxicity and/or complications from any intervention (ie, <= grade 1 or at baseline, excluding fatigue or alopecia) prior to initiating treatment; 14. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 15. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the research center); 16. Hepatitis B subjects who meet the following criteria can also be enrolled: (1) HBV viral load < 2.5 x 10^3 copies/ml (500 IU/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; 17. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the detection lim
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Disease control rate;Progression free survival;Overall survival;Duration of remission;Safety evaluation; | — |
Countries
China
Contacts
Public ContactBai Dousheng
Subei People's Hospital
Outcome results
None listed