Biliary Tract Cancer
Conditions
Interventions
intervening organization:Electroacupuncture treatment+Envolizumab+chemotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent and understand and agree to comply with the study requirements and evaluation schedule; 2. Age range from 18 to 75 years old on the date of signing ICF, male or female; 3. Advanced intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer that has not been previously treated and must be confirmed histologically or cytologically; 4. The tumor was evaluated as unresectable; 5. There is at least one measurable target that conforms to mRECIST, and the selected target must not have received prior treatment; 6. ECOG score 0-1; 7. The estimated survival time is greater than 12 weeks; 8. Weight > 30kg; 9 The functional level of the organs must meet the following requirements: (1) Adequate bone marrow reserve: absolute neutrophil count =1.5×109/L, white blood cell count =3×109/L, platelets =90×109/L, and hemoglobin =9 g/dL; (2) Liver: plasma albumin =2.8g/dL Serum bilirubin = 1.5×ULN, serum bilirubin = 3×ULN in patients with liver metastasis; AST and ALT in patients without liver metastasis =2.5×ULN, AST and ALT in patients with liver metastasis =5×ULN; (3) Kidney: serum creatinine =1.5×ULN; (4) Heart: left ventricular ejection fraction (LVEF) =50%; 10. Coagulation: prothrombin time (PT) =1.5×ULN, International Normalized ratio (INR) =1.5×ULN, activated partial thromboplastin time (aPTT) =1.5×ULN; 11. During the screening period, blood pressure was adequately controlled (defined as systolic blood pressure =150 mmHg and diastolic blood pressure = 90 mmHg) with or without antihypertensive drugs, and there was no change in antihypertensive treatment within 1 week before the first administration of the study drug; 12. Female or male subjects of reproductive age who are sterilized non-surgically must consent to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill or condom) during the study treatment period and for 6 months after the end of the study treatment period; Non-surgically sterilized female participants of reproductive age must have a negative HCG blood test within 7 days prior to study enrollment and must be non-lactating. 13. Subjects with HBV infection (characterized by HBSAg positive and/or anti-HBCAB positive according to local laboratory standards, HBV DNA>2000IU/ml) must receive antiviral therapy in accordance with institutional practice to ensure adequate viral suppression prior to inclusion; Participants were required to continue antiviral therapy during the study period and 6 months after receiving the last dose of the study intervention. For subjects who tested positive for anti-HBC but had no HBV DNA detected or HBV DNA=2000IU/ml, antiviral therapy was not required prior to study inclusion. These subjects will be tested at each cycle to monitor HBV DNA levels and begin antiviral therapy when HBV DNA>2000IU/ml is detected; Subjects with HBV DNA >2000IU/ml must begin and continue antiviral therapy during the study period and 6 months after receiving the last dose of the study intervention. 14. Voluntarily participate in this clinical trial, be willing and able to follow clinical visit and study related procedures, understand study procedures and have signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with carcinoma of ampulla; 2. Received chemotherapy and molecular targeted drugs for the treatment of biliary tract cancer; Patients who have received radiotherapy or interventional therapy for biliary tract cancer; People who have received immunotherapy for biliary tract cancer; 3. Patients who are not suitable for electroacupuncture due to known skin infection, edema, scar, etc.; 4. History of allogeneic organ transplantation; 5. Patients who received major surgical operations or active ulcers or wounds that were not fully healed within 1 month of the first use of the investigational drug (excluding central vein catheterization, tumor tissue biopsy or nasal feeding tube intubation); 6. Patients who have received live attenuated vaccine within 30 days before the first dose; 7. You are currently using, or have used, an immunosuppressive drug within 14 days prior to first dosing. The standard has the following exceptions: intranasal, inhaled, topical or injectable steroids (e.g., intra-articular injections); Systemic corticosteroid therapy not exceeding 10mg/ day of prednisone or its equivalent physiological dose; Prophylactic use of steroid hormones as a hypersensitivity reaction (e.g., CT scan pretherapy medication); 8.3 Active bleeding occurs within the first month; Arterial/venous thrombosis within 6 months; Hereditary or acquired bleeding (e.g., coagulation dysfunction) or thrombotic tendency; Is currently using or has recently used a full dose oral or injectable anticoagulant or thrombolytic drug for therapeutic purposes (10 days before the start of study therapy); Surgery (other than biopsy) or surgical incision not fully healed within 4 weeks prior to the study; Aspirin (> 325 mg/ day) or currently using or recently using dipyridamole, clopidogrel, and sitazole (10 days prior to study); 9. Have an active autoimmune or inflammatory disease, or a history of it, including inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), diverticulitis (other than diverticulitis), systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome (e.g., granulomatous vasculitis, Gray's disease, rheumatoid arthritis, pituitaritis, and uveitis), There are the following exceptions to this criteria: patients with vitiligo or hair loss; Patients with stable hypothyroidism after hormone replacement therapy (e.g., after Hashimoto's thyroiditis); Any chronic skin disease that does not require systemic treatment; Patients who have not had active disease in the last 5 years may be included, but only after consulting the study physician; People with celiac disease that can be controlled by diet alone; 10. Uncontrollable complications, including but not limited to: Persistent or active infections (other than those described above for HBV or HCV), symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or a condition that may limit compliance with study requirements, leading to a significantly increased risk of AE A psychiatric/social problem that affects the patient's ability to provide written informed consent; 11. A history of other primary malignancies, except for malignancies that have been treated for radical treatment and have no known active disease for =5 years prior to first administration and have a low potential risk of recurrence;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;overallsurvival; | — |
Countries
China
Contacts
Public ContactZheng Tongsen
Harbin Medical University Cancer Hospital
Outcome results
None listed