Biliary tract cancer
Conditions
Interventions
Experiment Group:Trastuzumab + chemotherapy + leflunomide. Simon's two-stage design is employed. The first stage requires enrolling 13 evaluable subjects
if more than 5 patients achieve ORR (Objective Response Rate), proceed to the second stage enrollment, with a total of 43 evaluable subjects needed for HER2-positive patients. For HER2-low expression
Sponsors
The Third Affiliated Hospital of Naval Medical University (Shanghai Eastern Hepatobiliary Surgery Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be signed before any trial-related procedures are implemented. 2. Male or female aged >=18 years and =3 months. 7. At least one measurable lesion according to RECIST v1.1 criteria. 8. ECOG PS score of 0-1. 9. Adequate organ function, with subjects meeting the following laboratory criteria: (1) Absolute neutrophil count (ANC) >=1.5x10^9/L without granulocyte colony-stimulating factor (G-CSF) use within the past 14 days; (2) Platelets >=90x10^9/L without blood transfusion within the past 14 days; (3) Hemoglobin >=9g/dL without blood transfusion or erythropoietin use within the past 14 days; (4) Total bilirubin =60 ml/min; (7) Normal coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) =50% or above the lower limit of the institutional normal range, whichever is lower. 11. For females of childbearing potential, a negative urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Day 1 of Cycle 1); if the urine pregnancy test result is indeterminate, a blood pregnancy test is required. Non-childbearing potential females are defined as those who are postmenopausal (amenorrheic for at least 1 year), or have undergone surgical sterilization or hysterectomy. 12. All subjects with reproductive potential (regardless of gender) must use highly effective contraception with a failure rate of less than 1% per year throughout the treatment period and for 120 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of any other malignancy outside the biliary tract within 5 years prior to first dose (excluding adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma after radical resection); 2. Ampullary tumor; 3. Currently participating in an interventional clinical study, or received other investigational drugs or used investigational devices within 4 weeks prior to first dose; 4. Received local therapy for biliary tract tumors, such as palliative radiotherapy, within 4 weeks prior to first dose. For patients who received radiotherapy more than 4 weeks prior to first dose, the following criteria must all be met for enrollment: (1) No ongoing radiation-related toxicities; (2) No requirement for corticosteroid use; (3) Exclusion of radiation hepatitis, radiation enteritis, etc.; 5. Received systemic systemic therapy with traditional Chinese medicine or immunomodulatory agents with anti-tumor indications (including thymosin, interferon, interleukin, except local use for controlling pleural effusion) within 2 weeks prior to first dose; 6. History of active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Note: (1) Replacement therapies (e.g., thyroid hormone, insulin, or physiological-dose corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; (2) History of known primary immunodeficiency; (3) Patients with only positive autoantibodies must be evaluated by the investigator to confirm presence of autoimmune disease; 7. Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 4 weeks prior to first dose (excluding intranasal, inhaled, or other local corticosteroids); (1) Note: Physiological-dose corticosteroids (<=10 mg/day prednisone or equivalent) are permitted; 8. Clinically uncontrolled pleural or peritoneal effusion (patients who do not require drainage or whose effusion does not significantly increase within 3 days after drainage cessation may be enrolled); 9. History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Known hypersensitivity to the active ingredient or excipients of the study drug; 11. Conditions affecting oral drug absorption, such as dysphagia, post-gastrointestinal resection, chronic diarrhea, or intestinal obstruction; 12. Inadequate recovery from toxicity and/or complications of any prior intervention prior to initiation of treatment (i.e., <= Grade 1 or back to baseline, excluding fatigue or alopecia); 13. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1/2 antibody positive); 14. Untreated active hepatitis B (defined as HBsAg-positive with HBV-DNA copy number exceeding the upper limit of normal in the local laboratory); Note: Hepatitis B patients meeting the following criteria may be enrolled: (1) HBV viral load <2.5×10^3 copies/mL (500 IU/mL) at first dose; patients must receive anti-HBV therapy throughout the study period; (2) Patients who are anti-HBc-positive, HBsAg-negative, anti-HBs-negative, and HBV-DNA-negative do not require prophylactic anti-HBV therapy but require close monitoring for viral reactivation; 15. Active HCV infection (HCV antibody-positive with HCV-RNA level above the lower limit of detection); 16. Received liv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objevtive Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Duration of Response;Progression-free Survival;Safety;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactFeng Feiling
The Third Affiliated Hospital of Naval Medical University (Shanghai Eastern Hepatobiliary Surgery Hospital)
Outcome results
None listed