Status:
UNKNOWN
Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Zhejiang University
Conditions:
Intrahepatic Cholangiocarcinoma by AJCC V8 Stage
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 Cisplati...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma)
- Has at least one measurable, evaluable lesions based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the research center investigator
- Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
- Is willing to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
- Has a life expectancy of greater than 3 months
- Has adequate organ function
- Has EOCG score 0 or 1
- Has willing to voluntarily participate in clinical trial and sign informed consent
Exclusion
- Histology includes fibrolamellar, hepatocytes, sarcomatoid liver cancer, hepatocytes, hepatocellular carcinoma and other components. Or has had previous biliary tract cancer (intra-or extra hepatic cholangiocarcinoma) or combined with other cancer with an exception of basal cell carcinoma and squamous cell carcinoma of the skin carcinoma in situ that has been radical treated.
- Has active tuberculosis and were receiving anti-tb treatment, or receiving anti-tb treatment within a year before were randomly assigned.
- Has symptomatic or poorly controlled circulatory disease, such as Congestive heart failure(NYHA III-IV), arrhythmia instability, type I angina, coronary heart disease, etc
- Has esophageal and gastric varices bleeding due to portal hypertension, or with history of inflammatory bowel disease, gastrointestinal perforation and intestinal obstruction, abdominal abscess, or chronic diarrhea.
- Has life-threatening bleeding or venous thromboembolism events occurred in the first six months before enrollment, or the patient was prone to severe bleeding or coagulation dysfunction, or was undergoing thrombolytic therapy
- Has active autoimmune disease requiring systemic treatment within the two years before enrollment , especially those with immunosuppressive drugs, who were unable to control or who needed large amounts of immunosuppressive drugs to control the disease, excluding topical glucose-corticosteroids or systemic use, and prednisone less than 10 milligrams per day
- Has central nervous system disease with symptoms, such as primary brain tumor, stroke, epilepsy, etc. Patients who have undergone central nervous system or known brain metastases
- Has acute or severe hepatitis infection, or a severe bacterial or bacterial infection in an active or clinically poorly controlled, or with congenital or acquired immune deficiency such human immunodeficiency virus (HIV) infected
- Has previous allogeneic stem cell or parenchymal organ transplantation, including after liver transplantation
- Has history of allergies to drugs involved in this study
- Women who are pregnant or lactating, or who do not want to use contraception during the trial.
Key Trial Info
Start Date :
April 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04413734
Start Date
April 22 2020
End Date
April 22 2024
Last Update
June 4 2020
Active Locations (1)
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1
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003