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HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Intrahepatic cholangiocarcinoma (ICC) has a poor prognosis. The aim of this study is to investigate the efficacy and safety of GP-HAIC combined with immunosuppressants in the treatment of initially unresectable ICC patients, as well as its role in conversion therapy. A prospective study was conducted on the data of locally advanced unresectable ICC patients receiving GC-HAIC combined with immunosuppressive therapy, evaluating the treatment efficacy and safety.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
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• Age: Age ≥ 18 years old.
• Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.
• Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).
• Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1.
• Liver function: Child Pugh classification A or B.
• Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol.
• Not receiving relevant treatment: Not receiving systematic treatment for ICC.
Locations
Other Locations
China
Shanghai Eastern Hepatobiliary Surgery Hospital
RECRUITING
Shanghai
Time Frame
Start Date:2025-01-01
Estimated Completion Date:2028-01-01
Participants
Target number of participants:50
Treatments
Experimental: HAIC combined with PD-L1 inhibitor
Hepatic arterial infusion chemotherapy (HAIC) combined with PD-L1 inhibitor 1.Therapy:hepatic~arterial infusion chemotherapy (HAIC) hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was~adopted, with the specific regimen as follows: Cisplatin 20mg/m2, maintained for 3 hours. Gemcitabine 0.6g/m2,~maintained for 1 hour , repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles~was determined by the investigator according to the patient's condition). 2. PD-L1 inhibitor Drug: Durvalumab~OR pembrolizumab Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5~of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W Pembrolizumab:~During combination therapy: 200 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle~(determined by the investigator); during maintenance therapy: 200 mg Q4W