Biliary tract carcinoma
Conditions
Interventions
Test group:Adebrelimab combined with Bevacizumab and GEMOX
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, signed an informed consent form, and cooperated with follow-up; 2. Age range from 18 to 75 years old, regardless of gender; 3. First line advanced Biliary tract carcinoma(BTC) confirmed by imaging or pathological diagnosis, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC); 4. Patients who have not received systematic treatment for BTC in the past and have received neoadjuvant or adjuvant therapy for more than 3 months are allowed to be included in this study; 5. Preliminary assessment of unresectable tumors (resectability assessment based on CT enhanced scanning or magnetic resonance imaging, NCCN 2022 5th edition standard); 6. At least one measurable lesion (according to RECIST v1.1 requirements, the spiral CT scan length diameter of the measurable lesion is = 10mm or the short diameter of the enlarged lymph nodes is = 15mm; lesions that have received local treatment in the past can be identified as target lesions after clear progression according to RECIST v1.1 standards); 7. ECOG PS: 0-1 points; 8. Expected survival time = 12 weeks; 9. The main organs are functioning normally and meet the following requirements (within 14 days before starting the study and treatment): (1) Blood routine examination: (No blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], no medication correction within 14 days prior to screening): 1) Hemoglobin [HB] = 90g/L; 2) Neutrophil absolute count [ANC] = 1.5 × 10^9/L; 3) Platelets [PLT] = 75 × 10^9/L; (2) The blood biochemistry test must meet the following criteria (no albumin transfusion in the 14 days before screening): 1) Serum total bilirubin [BIL] = 2 times the upper limit of normal value (ULN) 2) Alanine aminotransferase [ALT], aspartate aminotransferase [AST]50ml/min (Cockcroft Gault formula) Male: Cr clearance rate=(140 years old) × Weight/(72 × Blood Cr Female: Cr clearance rate=(140 years old) × Weight/(72 × Blood Cr × zero point eight five Weight unit: kg; Blood Cr unit: mg/mL; (3) Prothrombin time, partial thromboplastin time, plasma fibrinogen, and thrombin time are within the normal range; (4) Urinary protein<2+(if urinary protein = 2+, 24-hour urine protein quantification can be performed, and 24-hour urine protein quantification<1.0g can be included in the group); 10. Before patient enrollment, starting from the screening period, their TSH levels should be at the inhibitory level (<0.5 mU/L); 11. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days prior to enrollment, and voluntarily use appropriate methods of contraception during observation and within 8 weeks after the last administration of study medication; For males, surgical sterilization should be performed, or appropriate methods of contraception should be agreed upon during observation and within 8 weeks after the last administration of study medication;
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have appeared within the past 5 years, except for cervical carcinoma in situ or non melanoma skin cancer that has been appropriately treated. 2. Patients who have previously received treatment with Adelbolizumab and Bevacizumab. 3. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) according to the New York Heart Association (NYHA) standards for Grade II or above cardiac insufficiency or cardiac ultrasound examination: LVEF (Left Ventricular Ejection Fraction)450ms (males); QTc>470ms (female) (QTc interval is calculated using the Fridericia formula; if QTc is abnormal, it can be detected continuously three times every 2 minutes, and the average value is taken). 4. Individuals with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg) (based on the average BP reading obtained from = 2 measurements) are allowed to achieve the above parameters through the use of antihypertensive therapy; Previously experienced hypertensive crisis or hypertensive encephalopathy. 5. The patient has ascites or serious complications, including intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, renal insufficiency, cirrhosis, serious wounds, ulcers or fractures. 6. There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction. 7. Patients with a risk of gastrointestinal bleeding are not eligible for enrollment, including: (1) active peptic ulcer lesions and fecal occult blood (++); (2) Individuals with a history of black stools and vomiting blood within 3 months. 8. There have been incidents of thrombosis or embolism occurring within 6 months prior to the start of research treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. 9. Currently accompanied by interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy in the past, or other pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia that may interfere with immune related pulmonary toxicity assessment and management Subjects with idiopathic pneumonia or evidence of active pneumonia on screening chest computed tomography (CT) images or severely impaired lung function are allowed to have radiation pneumonia in the radiation field: active tuberculosis. 10. Active autoimmune disease or autoimmune disease history and possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis): the subject suffers from skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma in childhood has completely alleviated, Can be included in adult studies without any inter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival;disease control rate;Adverse events; | — |
Countries
China
Contacts
Public ContactJianbing Wu
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed