Clinical Study on the First-line Treatment of Advanced Biliary System Tumors With Tripley Monoclonal Antibody Combined With GEMOX Regimen

Exclusion Criteria

• •Previous treatment for biliary tract tumors, including radiotherapy, chemotherapy and immunotherapy (except for patients with recurrence more than 6 months after the end of previous adjuvant therapy)
• •Patients with active autoimmune diseases or a history of autoimmune diseases that may recur . Note: patients with the following diseases are not excluded and can be further screened:
• •1. controlled type 1 diabetes
• •2. hypothyroidism (which can be controlled with hormone replacement therapy alone)
• •3. controlled celiac disease
• •4. skin diseases that require no systemic treatment (e.g. Vitiligo, psoriasis, alopecia)
• •5. Any other disease that is not expected to recur in the absence of an external trigger
• •Any active malignancy within 2 years, except for specific cancers being studied in this trial and locally recurrent cancers that have been cured (such as excised basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ).
• •There was uncontrollable pleural effusion, pericardial effusion or ascites requiring frequent drainage within 14 days prior to enrollment (cytological examination of effusion was allowed).
• •Patients with gastrointestinal bleeding within the first two weeks of inclusion, or those with high blood risk as judged by the researchers.
• •Gastrointestinal perforation and/or fistula occurred within 6 months before admission.
• •Body weight loss≥20% in the first 2 months.
• •Lung diseases of clinical significance: interstitial pulmonary disease, non-infectious pneumonia, pulmonary fibrosis, acute pulmonary disease, etc.
• •Uncontrollable systemic diseases including diabetes, hypertension, etc.
• •Severe chronic or active infections, including tuberculosis and HIV infection, that require systemic antibacterial, antifungal or antiviral treatment.
• •Untreated chronic hepatitis b or chronic HBV carriers with hepatitis b virus (HBV) DNA exceeding 1000 IU/mL, or hepatitis c virus (HCV) RNA positive patients should be excluded. Nonactive hepatitis b surface resistance Original (HBsAg) carriers, treated and stable hepatitis b patients (HBV DNA \<1000IU/mL), and cured hepatitis c patients may be included.
• •Any of the following cardiovascular risk factors:
• •1. The occurrence of cardiogenic chest pain within no more than 28 days before enrollment was defined as moderate pain with limited daily living activities.
• •2. Symptomatic pulmonary embolism occurred within 28 days or less before enrollment.
• •3. Acute myocardial infarction occurred within less than 6 months before inclusion.
• •4. Any history of heart failure reaching the New York heart association level III/IV (appendix 5) less than 6 months prior to enrollment.
• •5. Ventricular arrhythmias of grade 2 or greater occurred within less than 6 months before inclusion, or were accompanied by supraventricular tachyarrhythmias requiring drug treatment.
• •6. Cerebrovascular accident (CVA) occurred within less than 6 months before inclusion.
• •Peripheral nerve disease is known to exceed NCI-CTCAE level 1. CTCAE 1However, patients with only deep tendon reflex (DTR) disappearance need not be excluded.
• •Moderate or severe renal impairment \[creatinine resolution equal to or less than 50 ml/min (based on the Cockroft and Gault equations)\], or serum creatinine \> normal upper limit (ULN).
• •Allergic to any component of the study drug.
• •Have undergone allogeneic stem cell transplantation or organ transplantation.
• •Corticosteroids (prednisone with a dose higher than 10 mg/d or similar drugs) should be used within 14 days before enrollment Isodose) or other immunosuppressant systemic therapy. Note: patients who currently or previously used any of the following steroid regimens may be included:
• •1. Adrenalin alternative steroids (prednisone≤10mg/d or equivalent)
• •2. Topical, intraocular, intraarticular, intranasal and inhaled corticosteroids with minimal systemic absorption.
• •3. Short-term (≤7 days) use of corticosteroids for prophylaxis (e.g Antiemetic agents for specific chemotherapy) or for the treatment of non-autoimmune conditions (such as delayed hypersensitivity caused by exposure to allergens).
• •Received live vaccine within 4 weeks prior to enrollment. (note: seasonal influenza vaccines are usually inactivated vaccines and are permitted. Vaccines used in the nasal cavity are live vaccines and should not be used.
• •Received: immunotherapy within 28 days prior to enrollment or within 5 half-lives (whichever is shorter, but at least 14 days) Treatment (such as interleukin, interferon, thymosin, etc.) or any experimental treatment.
• •Palliative radiotherapy was given within 14 days prior to enrollment.
• •Have received anti-pd-1, anti-pd-l1, anti-pd-l2 or any other specific targeted t-cell co-stimulation or checkpoint pathway antibody or drug therapy.
• •Receive major surgery within 28 days prior to enrollment, unless the surgery is minimally invasive (e.g., central venous catheterization through peripheral venipuncture \[PICC\]).
• •In the case of uncontrolled epilepsy, CNS disease or mental disorder, the investigator shall determine whether the clinical severity interferes with the signing of the informed consent or affects the patient's oral medication compliance.
• •There are potential medical conditions or alcohol/drug abuse or dependence that researchers consider to be detrimental to the study of drug administration or to the interpretation of drug toxicity or adverse events.