Unresectable intrahepatic cholangiocarcinoma (ICC)
Conditions
Interventions
Treatment Group:Transcatheter arterial chemoembolization combined with tislelizumab and lenvatinib
Control Group:Cisplatin and gemcitabine combined with tislelizumab
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Histopathological diagnosis of intrahepatic cholangiocarcinoma, unsuitable for radical surgery or recurrent after radical treatment, and without extrahepatic metastasis; 3.No prior systemic or transarterial interventional therapy related to intrahepatic cholangiocarcinoma; 4.At least one measurable lesion in the liver according to RECIST 1.1 criteria; 5.ECOG score 0-1; 6.Child-Pugh classification A; 7.Life expectancy >= 3 months; 8.Blood, liver, and kidney function (within 14 days prior to study start) meet the following criteria: a) Neutrophil count >=1.5 × 10^9/L; b) Platelet count >= 75 × 10^9/L; c) Hemoglobin concentration >= 90 g/L; d) Serum albumin concentration >= 30 g/L; e) Bilirubin =60 mL/min.
Exclusion criteria
Exclusion criteria: 1.Diffuse infiltrative liver disease; 2.Contraindications to TACE treatment exist; 3.Patients allergic to intravenous contrast agents; 4.Pregnant or lactating women, or subjects planning to undergo contraceptive procedures within 2 years; 5.Patients with co-infection of HIV and syphilis; 6.Patients with other concurrent malignant tumors or a history of other malignant tumors within 5 years prior to enrollment; 7.Patients receiving allogeneic organ transplantation; 8.Patients with severe dysfunction of the heart, kidneys, and other organs; 9.Severe clinically active infection > Grade 2 (NCI-CTCAE v5.0); 10.Patients with psychiatric disorders that may affect the informed consent process; patients unable to take oral medications; patients who participated in other drug clinical trials within 12 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Time to tumor progression;Progression-free survival period;Safety;Quality of Life Assessment;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactTeng Gaojun
Zhejiang Cancer Hospital
Outcome results
None listed