Cholangiocarcinoma
Conditions
Brief summary
The goal of this clinical trial is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with tislelizumab and regorafenib as first-line therapy in patients with locally advanced or metastatic cholangiocarcinoma. The main questions it aims to answer are: 1. What is the objective response rate (ORR) of this combination regimen according to RECIST 1.1 criteria 2. What are the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile associated with this treatment Participants will:Receive hepatic arterial infusion chemotherapy (HAIC)+ tislelizumab (PD-1 inhibitor)+regorafenib (oral multikinase inhibitor). Undergo regular imaging assessments to evaluate tumor response per RECIST 1.1.Be monitored for survival outcomes and adverse events throughout treatment and follow-up.
Interventions
DRUGHAIC Combined with Tislelizumab and Regorafenib
A combination therapy including hepatic arterial infusion chemotherapy (HAIC), tislelizumab, and regorafenib for first-line treatment of advanced cholangiocarcinoma.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years ; 2. Histologically or cytologically confirmed unresectable locally advanced or metastatic intra- or extrahepatic cholangiocarcinoma ; 3. Clinical stage III-IV according to the 8th edition of the AJCC TNM classification ; 4. No prior antitumor therapy; 5. Child-Pugh liver function class A or B ; 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 7. At least one measurable lesion per RECIST 1.1 ; 8. Adequate haematologic and hepatic/renal function; 9. Total bilirubin ≤ 2× upper limit of normal (patients who have undergone biliary drainage are eligible) ; 10. Adequate cardiac and pulmonary reserves to tolerate interventional procedures ; 11. Signed informed consent, good compliance, and ability to attend follow-up visits.
Exclusion criteria
1. Contraindications to transarterial chemoembolization, targeted therapy, or immunotherapy ; 2. Prior antitumor treatment ; 3. Concurrent primary malignancies; 4. Child-Pugh class C; 5. Severe cardiac, pulmonary, or renal dysfunction ; 6. Active autoimmune disease or need for long-term immunosuppressive therapy ; 7. Hypersensitivity to contrast agents or study drugs ; 8. Pregnancy or lactation; 9. Anticoagulant or thrombolytic therapy within 3 months before enrollment or bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR) | From first dose until disease progression, death, or up to approximately 24 months |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate (DCR) | From first dose until disease progression or last tumor assessment, whichever occurs first (up to approximately 24 months) |
| Progression-Free Survival (PFS) | From first dose to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) |
| Overall Survival (OS) | From first dose to death from any cause (up to approximately 36 months) |
| adverse events | From first dose until 30 days after the last dose of study treatment |
Countries
China
Outcome results
None listed