Biliary Tract Cancer
Conditions
Interventions
Intervention group:Received intravenous injection of Gemcitabine, cisplatin, and AK112
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following enrolment criteria to be enrolled in this trial: 1. be able to provide written informed consent and be able to understand and agree to comply with the study requirements and assessment schedule; 2. be >=18 years of age and 12 weeks; 7. weight > 30kg; 8. no prior anti-tumour therapy, including but not limited to other anti-CTLA-4, anti-VEGF, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies; 9. the level of organ function must meet the following requirements: (1) Adequate bone marrow reserve: absolute neutrophil count >=1.5x10^/L, white blood cell count >=3x10^9/L, platelets >=90x10^9/L , and haemoglobin >=9 g/dL; (2) Liver: plasma albumin >=2.8 g/dL; serum bilirubin =50%; 10. coagulation: prothrombin time (PT) <=1.5x ULN, international normalised ratio (INR) <=1.5x ULN, activated partial thromboplastin time (aPTT) <=1.5x ULN; 11. adequate control of blood pressure (defined as systolic blood pressure <= 150 mmHg and diastolic blood pressure <90 mmHg) during the Screening Period with or without antihypertensive medication and no change in antihypertensive treatment within 1 week prior to the first dose of study drug; 12. non-surgically sterilised female or male subjects of childbearing potential who agree to use a medically approved method of contraception (e.g., IUD, birth control pills, or condoms) for contraception for the duration of the study treatment period and for a period of 6 months after the end of the study treatment period; non-surgically sterilised female subjects of childbearing potential must have had a negative blood HCG test for a period of 7 days prior to enrolment in the study and must not be breastfeeding; 13. HBV-infected patients with detectable levels of HBV deoxyribonucleic acid (DNA) [=10 IUmL or above the limit of detection) as evidenced by hepatitis B surface antigen [ HbsAg] and/or hepatitis B core antibody (anti-HBc) positivity must be receiving antiviral therapy in accordance with the clinical institution's practice prior to formal treatment to ensure adequate viral suppression. Patients must be maintained on antiviral therapy for the duration of the study and for 6 months after administration of final study treatment. patients who test positive for anti-HBc but have undetectable HBV DNA (<10 IU/mL or below the limit of detection) are not required to be on antiviral therapy unless the HBV DNA exceeds 10 IU/mL or is above the limit of detection during the treatment period. Patients with active co-infection with HBV and HCV as evidenced by positive antibodies to anti-HCV and active co-infection with HBV and hepatitis D virus do not meet the inclusion criteria 14. participate voluntarily in this clinical trial, are willing and able to comply with clinical visits and study-related procedures, understand t
Exclusion criteria
Exclusion criteria: Subjects with any of the following characteristics are not eligible for inclusion in this study: 1. Patients with unresectable extrahepatic metastases; 2. Those who have received chemotherapy, molecular targeted drugs, and traditional Chinese medicine anti-tumor drugs for the treatment of cholangiocarcinoma; Individuals who have received radiotherapy or interventional therapy for cholangiocarcinoma (excluding those who have received PTCD treatment or common bile duct stent); Individuals who have received immunotherapy for cholangiocarcinoma; You can simply say that you have received treatment for bile duct cancer in the past; 3. Have a history of homologous organ transplantation; 4. Individuals who have undergone major surgical procedures, active ulcers, or incomplete wound healing within one month of the first use of the investigational drug (excluding central venous catheterization, tumor tissue biopsy, or nasogastric intubation); 5. Those who are expected to undergo elective surgery during the study period; 6. Individuals who have received transfusions of blood products or injections of hematopoietic colony-stimulating growth factors (such as G-CSF, GMCSF, M-CSF) within 14 days of their first use of the study drug; 7. Those who have received attenuated live vaccines within 30 days before the first administration; 8. Currently in use, or used immunosuppressive drugs within 14 days prior to the first administration. This standard has the following exceptions: intranasal, inhalation, topical steroids, or injection of steroids (such as intra-articular injection); Systemic corticosteroid treatment with prednisone not exceeding 10mg/day or its equivalent physiological dose; Prophylactic use of steroids as a preventive measure for hypersensitivity reactions (such as CT scan pre-treatment medication); 9. Suffering from active autoimmune or inflammatory diseases, or having a history of related illnesses, including inflammatory bowel disease (such as colitis or Crohn's disease), diverticulitis (excluding diverticulitis), systemic lupus erythematosus, sarcoidosis syndrome, or Wagner's syndrome (such as granulomatous vasculitis, Gray's disease, rheumatoid arthritis, pituitary inflammation, and uveitis). There are the following exceptions to this standard: patients with vitiligo or hair loss; Stable hypothyroidism patients receiving hormone replacement therapy (For example, after Hashimoto's thyroiditis); Any chronic skin disease patient who does not require systemic treatment; Patients with no active diseases within the past 5 years can be included, but only after consulting the research doctor can they be included; Patients with celiac disease who can be controlled solely by diet; 10. Uncontrollable complications, including but not limited to: persistent or active infection (except for the above HBV or HCV), symptomatic congestive heart failure, uncontrollable diabetes, uncontrollable hypertension, unstable angina pectoris, uncontrollable arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or mental illness/social problems that may limit compliance with research requirements, significantly increase AE risk or affect the ability of subjects to provide written informed consent; 11. Have a history of severe bleeding tendency or coagulation dysfunction; There are significant clinically significant bleeding symptoms within one month before the first administration, including but not limited to gastroi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression free survival;Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactZheng Tongsen
Harbin Medical University Cancer Hospital
Outcome results
None listed