Carcinoma of biliary tract
Conditions
Interventions
Group 1:One course of hepatic arterial infusion chemotherapy, followed by a course of intravenous chemotherapy
Group 2:Two courses of intravenous chemotherapy
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients voluntarily join this study and sign an informed consent form; 2) Aged 18 years or older (calculated as of the date of signing the informed consent), both males and females can participate; 3) Patients with pathologically diagnosed advanced biliary malignancies; 4) Subjects must be able to provide fresh or archived tumor tissue (formalin-fixed, paraffin-embedded [FFPE] tissue blocks or at least 5 unstained FFPE slides) and their pathology reports. If the number of unstained slides provided by the subject is less than 5 or the tumor tissue is unavailable (e.g., depleted due to previous diagnostic testing), enrollment may be permitted depending on the circumstances after discussion; 5) Subjects who are not suitable for surgery or have progressed after surgery and/or local treatment; 6) For patients who have progressed after local treatment, the local treatment (including but not limited to surgery, radiotherapy, arterial embolization, arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks prior to the baseline imaging scan, and any toxicities resulting from the local treatment (except for hair loss) must have recovered to a rating of =10mm on spiral CT scan or a short diameter of enlarged lymph nodes of >=15mm; lesions that have previously undergone local treatment can be considered target lesions if they show clear progression according to RECIST v1.1 standards); 9) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 (ECOG scoring standards are in Appendix 1); 10) Expected lifespan of >=12 weeks; 11) Basic normal function of major organs, with no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, etc., and no immunodeficiency diseases, meeting the protocol requirements: a) Complete blood count examination: (excluding hemoglobin, no blood transfusions, use of Granulocyte Colony-Stimulating Factor [G-CSF] in the past 14 days, and no corrective treatment in the past 7 days); i. Hemoglobin >= 90 g/L; ii. Neutrophil count >= 1.5 × 10^9/L; iii. Platelet count >= 50 × 10^9/L; b) Biochemical tests: (no albumin transfusion within 14 days) i. Serum albumin >= 29 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 50 mL/min (Cockcroft-Gault formula as follows): Male: Cr clearance = ((140 - age) × weight) / (72 × serum Cr) Female: Cr clearance = ((140 - age) × weight) / (72 × serum Cr) × 0.85 Weight units: kg; Serum Cr units: mg/mL; v. Urine protein = 2, a 24-hour urine protein quantification may be performed, and if 24h urine protein quantification < 1.0 g, can be included); c) Coagulation function: Activated partial thromboplastin time (APTT) and International Normalized Ratio (INR) <= 1.5 × ULN (for those on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin and INR in the expected therapeutic range for anticoagulants can be screened); d) Thyroid-stimulating hormone (TSH) <= UL
Exclusion criteria
Exclusion criteria: 1.Have other active malignant tumors except BTC within 5 years or at the same time. Localized tumors that have been cured, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc., can be included in the group; 2.Patients who are about to undergo or have previously received organ or allogeneic bone marrow transplantation; 3.Have been treated with other experimental drugs within 28 days before starting the study treatment; 4.Moderate and severe ascites with clinical symptoms requires therapeutic puncture, drainage or Child-Pugh score > 2 (except those who only show a small amount of ascites on imaging but are not accompanied by clinical symptoms); Uncontrolled or moderate or above pleural effusion and pericardial effusion; 5.There is a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding within 6 months before the start of the study treatment, such as: bleeding-risk or severe esophageal and gastric varices, local active gastrointestinal ulcer lesions, and persistent fecal occult blood positive. You can not enter the group (if the fecal occult blood is positive in the baseline period, you can recheck it, if it is still positive after the recheck, you need to have a gastroscopy (EGD), and if the esophageal and gastric varices indicate the risk of bleeding, you can not enter the group); 6.Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of the study treatment; 7.Have suffered from intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting the study and treatment, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition or tube feeding; 8.Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombosis tendency, such as hemophilia patients; At present, or in the near future (within 10 days before the start of the study treatment), full-dose oral or injection anticoagulants or thrombolytic drugs have been used for therapeutic purposes (low-dose aspirin and low-molecular-weight heparin are allowed for preventive use); 9.Aspirin (> 325mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazol are currently being used or recently used (within 10 days before the start of study treatment); 10.Thrombosis or embolism occurred within 6 months before the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) and pulmonary embolism; 11.There are poorly controlled clinical symptoms or diseases of the heart, such as: a) According to the standards of the New York Heart Association (NYHA) for grade II or above cardiac insufficiency or echocardiography examination: LVEF (left ventricular ejection fraction) 450ms (male); QTc > 470ms (for females) (The QTc interval is calculated using the Fridericia formula; If the QTc is abnormal, three consecutive tests can be conducted at intervals of 2 minutes, and the average value can be taken. 12. Patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate;Disease progression time;Disease control rate;Duration of remission;Overall survival;To evaluate adbelizumab and antilotinib combined with hepatic arterial infusion chemotherapy or intravenous infusion Safety of pulse chemotherapy for first-line treatment of advanced biliary tract tumors; | — |
Countries
China
Contacts
Public ContactJie Ma
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed