NCT05350943
Enrolling By Invitation
Phase 2
Phase II Study to Evaluate the Efficacy and Safety of HAIC Combined With Toripalimab and Donafenib in Patients With Advanced Biliary Tract Cancer
Lu Wang, MD, PhD1 site in 1 country70 target enrollmentMarch 1, 2022
ConditionsBiliary Tract Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Oxaliplatin
- Conditions
- Biliary Tract Adenocarcinoma
- Sponsor
- Lu Wang, MD, PhD
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
Lu Wang, MD, PhD
professor
Fudan University
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%;
Exclusion Criteria
- Not provided
Arms & Interventions
HAIC+Toripalimab+Donafenib
HAIC(GEMOX)+Toripalimab+Donafenib
Intervention: Oxaliplatin
HAIC+Toripalimab+Donafenib
HAIC(GEMOX)+Toripalimab+Donafenib
Intervention: HAIC
HAIC+Toripalimab+Donafenib
HAIC(GEMOX)+Toripalimab+Donafenib
Intervention: Gemcitabine
HAIC+Toripalimab+Donafenib
HAIC(GEMOX)+Toripalimab+Donafenib
Intervention: Toripalimab
HAIC+Toripalimab+Donafenib
HAIC(GEMOX)+Toripalimab+Donafenib
Intervention: Donafenib
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: through study completion, an average of 2 year
the sum of complete response rate and partial response rate
Secondary Outcomes
- Disease Control rate (DCR)(through study completion, an average of 2 year)
- Quality of life questionnaire(through study completion, an average of 2 year)
- Progression-free survival (PFS)(through study completion, an average of 2 year)
- Overall survival (OS)(through study completion, an average of 2 year)
- Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0.(through study completion, an average of 2 year)
Study Sites (1)
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