The goal of this clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are: * Whether combined therapy using D-TACE, Gem/Cis, and PD-1 works well to convert unresectable ICC to resectable. * Whether combined therapy using D-TACE, Gem/Cis, and PD-1 is safe. Participants will receive D-TACE (CalliSpheres with Gem 30 mg), camrelizumab (200 mg) plus gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2), and 24 months follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
200mg on day1 of every 3 weeks, starting on day1 of cycle1
1000mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1
25mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1
used for D-TACE
TACE with Cisplatin-Eluting Beads (with Cis 30mg). More TACE can be done if clinically necessary.
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGConversion rate
Rate of unresectable ICC convert to resectable in combination therapy
Time frame: 12 months
Incidence of adverse events
Rate of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months
Objective Response Rate (ORR)
ORR according to RECIST 1.1 using investigator assessment
Time frame: 12 months
Deepness of response (DpR)
DpR according to RECIST 1.1 using investigator assessment
Time frame: 12 months
Disease control rate (DCR)
DCR according to RECIST 1.1 using investigator assessment
Time frame: 12 months
Rate of R0 resection
R0 resection is defined as no tumor remains at the cutting edge and no tumor cells remain at the cutting edge under the microscope
Time frame: 12 months
Overall Survival (OS)
OS is defined as the time from date of combined theray start to the date of death from any cause or to the date of last follow-up if patients are alive.
Time frame: 12 months
Progression-free Survival (PFS)
From the beginning date of combined therapy to the date of disease progression. PFS according to RECIST 1.1 using investigator assessment
Time frame: 12 months
Recurrence-free Survival (RFS)
RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. RFS according to RECIST 1.1 using investigator assessment
Time frame: 12 months
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