HAIC Combined With Toripalimab and Donafenib for Advanced BTC
- Conditions
- Biliary Tract Adenocarcinoma
- Interventions
- Registration Number
- NCT05350943
- Lead Sponsor
- Lu Wang, MD, PhD
- 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 Toripalimab and Tyrosine Kinase Inhibitor Donafenib in patients with advanced biliary tract cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 70
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HAIC+Toripalimab+Donafenib HAIC HAIC(GEMOX)+Toripalimab+Donafenib HAIC+Toripalimab+Donafenib Donafenib HAIC(GEMOX)+Toripalimab+Donafenib HAIC+Toripalimab+Donafenib Gemcitabine HAIC(GEMOX)+Toripalimab+Donafenib HAIC+Toripalimab+Donafenib Toripalimab HAIC(GEMOX)+Toripalimab+Donafenib HAIC+Toripalimab+Donafenib Oxaliplatin HAIC(GEMOX)+Toripalimab+Donafenib
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) through study completion, an average of 2 year the sum of complete response rate and partial response rate
- Secondary Outcome Measures
Name Time Method Disease Control rate (DCR) through study completion, an average of 2 year the sum of complete response rate, partial response rate and stable disease rate
Quality of life questionnaire through study completion, an average of 2 year The concept of comprehensively evaluating the quality of life
Progression-free survival (PFS) through study completion, an average of 2 year Time from randomization to disease progression
Overall survival (OS) through study completion, an average of 2 year Time from randomization to death for any cause
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0. through study completion, an average of 2 year Unforeseen medical events occurred when the subjects received drug treatment or research, but there is not necessarily a causal relationship with the drugs used.
Severe adverse events
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China