Biliary tract neoplasm, BTC
Conditions
Interventions
Intervention group:Cadonilimab plus gemcitabine and cisplatin
Sponsors
The second hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Before any trial-related procedures are implemented, a written informed consent must be signed.; 2. Men or women aged 18 to 75 years. 3. Histologically or cytologically confirmed, unresectable locally advanced or metastatic biliary tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma). 4. No prior systemic therapy, and at least 6 months have elapsed since adjuvant therapy was completed. 5. Expected survival time > 3 months. 6. At least 1 measurable lesion according to RECIST1.1 criteria. 7. ECOG PS score of 0-1. 8.Sufficient organ function is required, and the patient must meet the following laboratory criteria: 1) ANC (neutrophil absolute count) = 1.5x10^9/L within the past 14 days without the use of granulocyte colony-stimulating factor; 2) Platelet count = 90x10^9/L within the past 14 days without blood transfusion; 3) Hemoglobin > 9g/dL within the past 14 days without blood transfusion or the use of erythropoietin. 4) Total bilirubin = 1.5 x upper limit of normal (ULN); 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (ALT or AST = 5 x ULN for patients with liver metastasis); 6) Creatinine = 1.5 x ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) = 60 ml/min; 7) Normal coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) = 1.5 x ULN; 8) Normal thyroid function, defined as a thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be eligible; 9) Cardiac enzymes within normal range (subjects with laboratory abnormalities of minor clinical significance that the investigator determines to be not clinically significant may also be eligible). 9. For female patients of reproductive age, urine or serum pregnancy tests should be conducted within 3 days prior to the first study drug administration (Day 1 of Cycle 1) and the results should be negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Non-reproductive-age women are defined as those who have been postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy. 10. If there is a risk of pregnancy, all patients (regardless of gender) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1.Patients who have been diagnosed with other malignant neoplasms (excluding basal cell carcinoma of the skin that has been cured by surgery, squamous cell carcinoma of the skin that has been cured by surgery, or in situ carcinoma that has been cured by surgical resection) within 5 years prior to the first dose of study drug. 2.Tumors in the ampulla of Vater 3.Patients who are currently participating in an interventional clinical study or who have received other investigational drugs or investigational devices for treatment within 4 weeks prior to the first dose of study drug. 4.Patients who have received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137). 5.Patients who have received palliative radiotherapy for biliary tract tumors, except postoperative adjuvant radiotherapy. 6.Patients who have received systemic treatment with immunomodulatory or anti-tumor effects of traditional Chinese medicine within 2 weeks prior to the first dose of study drug(including thymosin, interferon, and interleukin, excluding local use for controlling pleural effusion). 7. History of active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying agents, glucocorticoids, or immunosuppressants) within 2 years prior to first dose. Alternative therapies (e.g., thyroid hormone, insulin, or bioidentical glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatments. History of primary immunodeficiency. Only patients with positive autoimmune antibodies will be confirmed by the investigator for the presence of autoimmune disease. 8.Patients who have received systemic corticosteroids for treatment within 4 weeks prior to the first dose of study drug (excluding nasal, inhalation, or other local use of corticosteroids). Or any other form of immunosuppressive therapy. 9.Patients with clinically uncontrollable pleural effusion/ascites.(Patients who do not require drainage or have stopped drainage for 3 days without a significant increase in effusion can be enrolled.) 10.Patients with a history of allogeneic organ transplantation (except for corneal transplantation). 11.Patients with a history of hypersensitivity to any component of the study drug, cadonilimab, or any excipient. 12. Before starting treatment, the patient has not fully recovered from any toxicity and/or complications caused by previous interventions (i.e., = Grade 1 or back to baseline, excluding fatigue or alopecia) 13.Patients who have not fully recovered 13. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies) 14. Untreated active hepatitis B (defined as positive for HBsAg and detectable HBV-DNA copy number above the normal value limit of the laboratory at the study center) Note: The following criteria must be met for eligibility of hepatitis B (HB) patients: 1) HBV viral load < 2.5 × 10^3 copies/ml (500 IU/ml) prior to first dose; patients should receive anti-HBV treatment throughout the study treatment period. 2) For patients with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-), preventive anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary. 15. Active HCV infection participants (HCV antibody positive and HCV-RNA level above the detection limit) 16. Do not receive the vaccine within 4 weeks of receiving a live attenuated vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Progression-free survival, PFS;Overall survival, OS;Duration of response, DoR;Safety; | — |
Countries
China
Contacts
Public ContactHui Zhang
The second hospital of Lanzhou University
Outcome results
None listed