Intrahepatic Cholangiocarcinoma by AJCC V8 Stage Clinical Trial
Official title:
Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma: A Exploratory Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | April 22, 2024 |
| Est. primary completion date | April 22, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Zhejiang University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Time from first randomization to the first documented disease progression or death due to any cause, whichever occurs first. | Observation period 48 months | |
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to death due to any cause. | Up to 48 months | |
| Secondary | 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 | Up to 48 months | |
| Secondary | 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 | Up to 48 months | |
| Secondary | 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 | Up to 48 months | |
| Secondary | 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 | Up to 48 months | |
| Secondary | Adverse Events (AE) | Safety evaluation was done continuously during treatment by using CTCAE 5.0 | Up to 48 months |