Biliary Tract Cancer
Conditions
Interventions
Adebrelimab+NALIRIFOX Group:Adebrelimab+NALIRIFOX
Adebrelimab+GC Group:Adebrelimab+GC
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent prior to the initiation of any trial-related procedures 2.Aged >= 18 years 3.Histologically or cytologically confirmed locally advanced or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) that is unresectable. 4.No prior systemic therapy, neoadjuvant therapy, or radical surgery; patients with disease recurrence 6 months after adjuvant therapy are eligible for enrollment. 5.Expected survival time > 3 months. 6.At least one measurable lesion according to the RECIST 1.1 criteria. 7.ECOG Performance Status score of 0-1. 8.Adequate organ function, with subjects meeting the following laboratory indicators: 1) Absolute Neutrophil Count (ANC) >= 1.5 × 10?/L without the use of granulocyte colony-stimulating factor within the past 14 days. 2) Platelet count >= 90 × 10?/L without blood transfusion within the past 14 days. 3) Hemoglobin > 9 g/dL without blood transfusion or use of erythropoietin within the past 14 days. 4) Total bilirubin = 60 ml/min. 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 × ULN. 8) Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within the normal range. Subjects with baseline TSH outside the normal range are eligible if total T3 (or FT3) and FT4 are within the normal range. 9) Myocardial enzyme profile within the normal range (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator are also eligible). 9.For female subjects of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days prior to the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test result is inconclusive for negativity, a blood pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. 10.All subjects (both male and female) with reproductive potential must use contraceptive methods with an annual failure rate of less than 1% throughout the treatment period and until 120 days after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of other malignant diseases outside the biliary tract within 5 years prior to the first administration (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ). 2.Ampullary carcinoma. 3.Currently participating in an interventional clinical study, or having received other study drugs or used study devices within 4 weeks prior to the first administration. 4.Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137). 5.Prior palliative radiotherapy for biliary tract cancer, excluding postoperative adjuvant radiotherapy. 6.Systemic treatment with Chinese herbal medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for controlling pleural effusion) within 2 weeks prior to the first administration. 7.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment. 8.Known history of primary immunodeficiency. 9.Patients with only positive autoantibodies must be evaluated by the investigator to confirm the presence of autoimmune disease. 10.Receipt of systemic glucocorticoid therapy (excluding nasal, inhaled, or other forms of topical glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks prior to the first administration of the study drug. Note: Physiological doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent) are allowed. 11.Clinically uncontrollable pleural effusion/ascites (patients who do not require effusion drainage or have no significant increase in effusion 3 days after stopping drainage are eligible). 12.Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 13.Known hypersensitivity to the active ingredients or excipients of liposomal irinotecan and Adebrelimab used in this study. 14.Failure to fully recover from toxicity and/or complications caused by any intervention prior to the start of treatment (i.e., <= Grade 1 or return to baseline, excluding fatigue or alopecia). 15.Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies). 16.Untreated active hepatitis B (defined as positive HBsAg with HBV-DNA copy number exceeding the upper limit of normal of the laboratory in the participating study center).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;The incidence of AE;Disease control rate, DCR;PFS;Duration of remission, DOR;Overall survival, OS ;Standardized score of the EORTC QLQ-C30; | — |
Countries
China
Contacts
Public ContactZhu Qing
West China Hospital, Sichuan University
Outcome results
None listed