Overview

Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma

Status:
Recruiting
Trial end date:
2024-04-22
Target enrollment:
0
Participant gender:
All
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 Cisplatin in patients who were advanced intrahepatic cholangiocarcinoma with no chance for primary surgery.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang University
Treatments:
Cisplatin
Gemcitabine
Criteria
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.