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To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.
Enrollment
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Volunteers
Inclusion criteria
The patient had good compliance, could understand the research process of this study, and signed a written informed consent.
Age ≥18 years.
Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs.
Subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure.
Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
Has a life expectancy of greater than 3 months.
LVEF≥50%.
Appropriate organ function is defined as follows: (Hematology and blood biochemistry tests must be completed within 14 days prior to enrollment, and the following criteria are met):
Patients with biliary obstruction should receive adequate biliary drainage.
Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecias, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk).
non-pregnant or lactating female; Effective contraception should be used by female/Male of childbearing age during the study period and for 6 months after the end of study treatment.
There were no contraindications for the use of irinotecan liposomes and capecitabine.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Yi Ba, PHD
Data sourced from clinicaltrials.gov
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