HAIC Combined With Toripalimab and Donafenib for Advanced BTC

• Status: Enrolling by invitation
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lu Wang, MD, PhD
• Treatments: Gemcitabine; Oxaliplatin

Criteria

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.