Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are: * To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer * To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The patient had good compliance, could understand the research process of the study, and signed a written informed consent;

• Age ≥18 years, ≤75 years;

• Histologically or cytologically confirmed cholangiocarcinoma;

• Documented metastatic disease;

• At least one measurable lesion according to RECIST v1.1;

• Disease progression after gemcitabine + immunotherapy;

• For patients whose disease recurred after curative resection (R0 or R1), previous adjuvant 5-FU-based chemotherapy is allowed if there is at least 6 month-interval between the last dose of adjuvant chemotherapy and recurrence of disease;

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-1;

• The expected survival time is greater than 3 months;

⁃ Having adequate organ function, as defined below:

∙ Absolute neutrophil count (ANC) ≥1.5\*109/L

‣ Hemoglobin ≥90g/dL

‣ Platelets (PLT) ≥100\*109/L

‣ Total bilirubin \< 1.5 times Upper Normal Value (ULN)

‣ Chemical examination of liver function index (AST\&ALT) \< 2.5 times Upper Limit of Normal (ULN)

‣ Serum creatinine (Cr) ≤1.5×ULN

⁃ Non-pregnant or lactating women; Effective contraception should be used by women/men of childbearing age during the study period and for 6 months after the end of study treatment-

Locations
Other Locations
China
Tianjin Cancer Hospital Airport Hospital
RECRUITING
Tianjin
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 30
Treatments
Study Arms
Drug: Irinotecan Hydrochloride Liposome Injection The recommended dose and regimen of Irinotecan Hydrochloride Liposome Injection is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 3 weeks.It can be combined or partially combined immunotherapy.
Related Therapeutic Areas
Sponsors
Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov

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