Status:
UNKNOWN
HAIC Combined With Toripalimab and Donafenib for Advanced BTC
Lead Sponsor:
Lu Wang, MD, PhD
Conditions:
Biliary Tract Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a single center, single arm, phase II, prospective study to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) combined with PD-1 inhibitor immunotherapy Toripal...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18 to 80 years of age, of any sex;
- Histologically/Cytologically confirmed diagnosis of unresectable advanced adenocarcinoma of the gallbladder, intrahepatic bile duct and extrahepatic bile duct.
- At least one measurable lesion umder CT/MRI as defined by RECIST1.1 criteria
- Patients must have adequate organ and marrow function as defined below:
- Blood test:
- Hemoglobin (HB) ≥90 g/L Absolute neutrophil count (ANC) ≥1.5×10\^9/L； Platelet (PLT) ≥80×10\^9/L；
- Biochemical test:
- total bilirubin≤2×ULN (institutional upper limit of norm) AST(SGOT)/ALT(SGPT)≤2.5 ×ULN creatinine clearance≥ 50 ml/min as calculated by the Cockroft-Gault formula
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
- Indocyanine Green Retention Rates at 15 min (ICGR15\<22%;
- Life expectancy of \> 3 months;
- Exclusion Criteria
- Patients with other malignant tumors should be excluded
- Female patients who are pregnant or breast-feeding. Female patients who are pregnant during the study should also exit.
- Patient has enter any other clinical trails within 4 weeks prior to study entry.
- Patient known with a severe and/or uncontrolled medical disease.
- Chronic non-healing wound/bone fracture
- History of organ transplant
- Patients with abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), those have bleeding tendency (14 days prior to randomization must meet: INR is within the normal range without any use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogous therapy; use for preventive purposes is permitted provided that the international normalized ratio of prothrombin time (INR) ≤ 1.5, take low-dose warfarin (1 mg PO, QD) or low-dose aspirin (do not exceed 100 mg per day);
- Previous history of aterial/venous thrombosis such as cerebrovascular accidents, pulmonary embolism or deep venous thrombosis within one year prior to patients recruitment.
- Hitstory of psychiatric drug abuse and hasn't come clean, or with psychiatric illness/social situations that would limit compliance with study requirements
- History of immunodeficiency, or other acquired/congenital immunodeficiency diseases
- Concomitant diseases that severely endanger the safety of the subject or affect the study completion according to the judgment of the investigator
- Willingness to sign a written informed consent document, with good compliance.
Exclusion
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05350943
Start Date
March 1 2022
End Date
November 1 2023
Last Update
October 18 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200062