Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT04413734|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic Cholangiocarcinoma by AJCC V8 Stage||Drug: Combination therapy Drug: Mono-chemotherapy||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma: A Exploratory Clinical Trial|
|Actual Study Start Date :||April 22, 2020|
|Estimated Primary Completion Date :||April 22, 2022|
|Estimated Study Completion Date :||April 22, 2024|
Experimental: Triprilumab in combination with chemotherapy of GP
Triprilumab, 240 mg, every 3 weeks (Q3W), Day 1 of each 3 week cycle PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity .
Drug: Combination therapy
Triprilumab by intravenous infusion accompanying with Gemcitabine plus Cisplatin
Active Comparator: Mono-chemotherapy of GP
Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity.
Gemcitabine plus Cisplatin by intravenous infusion
Other Name: Gemcitabine Injection plus Cisplatin Injection
- Progression-Free Survival (PFS) [ Time Frame: Observation period 48 months ]Time from first randomization to the first documented disease progression or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to 48 months ]Overall survival is defined as the time from randomization to death due to any cause.
- Objective Response Rate (ORR) per RECIST 1.1 [ Time Frame: Up to 48 months ]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
- Disease Control Rate(DCR) [ Time Frame: Up to 48 months ]DCR is defined as the percentage of participants who have a confirmed Complete Response or Partial Response as assessed by RECIST 1.1
- Myopathologic response(MPR) [ Time Frame: Up to 48 months ]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
- Conversion surgical resection(R0) rate [ Time Frame: Up to 48 months ]the ratio of patients successfully converted into radical surgical resection by the treatment plan, in which the margin of the liver is negative
- Adverse Events (AE) [ Time Frame: Up to 48 months ]Safety evaluation was done continuously during treatment by using CTCAE 5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413734
|Contact: Tingbo Liangemail@example.com|
|Contact: Xueli Baifirstname.lastname@example.org|
|the First Affiliated Hospital, School of Medicine, Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310003|
|Contact: Liang TingBo, MD, PHD 086-571-87236688 email@example.com|