Clinical trial NCT05350943: HAIC Combined With Toripalimab and Donafenib for Advanced BTC
Official title: Phase II Study to Evaluate the Efficacy and Safety of HAIC Combined With Toripalimab and Donafenib in Patients With Advanced Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Biliary Tract Adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Disease Control rate (DCR)
timeFrame: through study completion, an average of 2 year
measure: Progression-free survival (PFS)
timeFrame: through study completion, an average of 2 year
measure: Overall survival (OS)
timeFrame: through study completion, an average of 2 year
measure: Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0.
timeFrame: through study completion, an average of 2 year
measure: Quality of life questionnaire
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: