This study is designed to observe and evaluate the safety and the efficacy of the anti-programmed-death-1 antibody (anti-PD-1) Triprilumab in combination with chemotherapy of Gemcitabine PLUS Cisplatin in patients who were advanced intrahepatic cholangiocarcinoma with no chance for primary surgery.
Intrahepatic cholangiocarcinoma, also known as intrahepatic cholangiocarcinoma, is derived from intrahepatic bile duct epithelial cells, the second most common primary liver malignant tumor in china. but most (60% -70%) patients is diagnosed at the advanced stage . Gemcitabine plus cisplatin is the standard first-line advanced treatment recommended in international and domestic guidelines, but the treatment effect remains to be improved. The clinical benefits of immune therapies for HCC are emerging. Early clinical data already show the safety of immune checkpoint inhibition. This study is to analyze the safety and efficacy of immunotherapy Triprilumab Injection combined with Gemcitabine Injection plus Cisplatin Injection in patients with advanced intrahepatic cholangiocarcinoma. Patients who were aged 18 to 80 years with a histological or cytological diagnosis of intrahepatic cholangiocarcinoma,locally advanced or multiple liver metastases, including postoperative occurrence, will be enrolled in this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Triprilumab by intravenous infusion accompanying with Gemcitabine plus Cisplatin
Gemcitabine plus Cisplatin by intravenous infusion
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGProgression-Free Survival (PFS)
Time from first randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Observation period 48 months
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.
Time frame: Up to 48 months
Objective Response Rate (ORR) per RECIST 1.1
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by RECIST 1.1
Time frame: Up to 48 months
Disease Control Rate(DCR)
DCR is defined as the percentage of participants who have a confirmed Complete Response or Partial Response as assessed by RECIST 1.1
Time frame: Up to 48 months
Myopathologic response(MPR)
DCR is defined as the proportion of patients with residual survival tumor ≤10%, the evaluation requires two liver cancer pathologists to evaluate and judge. If the difference between the two pathologists' evaluation is ≤10%, the average value is taken as the pathological remission rate. If the difference is greater than 10%, a third pathologist is required to evaluate, and then the average of the two with a difference of less than 10% will be taken
Time frame: Up to 48 months
Conversion surgical resection(R0) rate
the ratio of patients successfully converted into radical surgical resection by the treatment plan, in which the margin of the liver is negative
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Time frame: Up to 48 months
Adverse Events (AE)
Safety evaluation was done continuously during treatment by using CTCAE 5.0
Time frame: Up to 48 months