Extrahepatic Cholangiocarcinoma Clinical Trial
Official title:
A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma
This is an open-label, single-arm, multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with TACE in the treatment of extrahepatic cholangiocarcinoma.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | May 15, 2024 |
Est. primary completion date | May 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age > 18 years and < 75 years - both men and women - ECOG performance status score 0-2 points - Child-Pugh score = 7 points - Expected survival = 12 weeks - Patients with histologically or cytologically confirmed extrahepatic cholangiocarcinoma, patients with obstructive jaundice need to return to normal after drainage - At least one measurable lesion [spiral CT scan = 10 mm (CT scan slice thickness no greater than 5 mm)] (RECIST Version 1.1) - Vital organ function meets the following requirements: a. Absolute neutrophil count (ANC) = 1.5 × 109/L; b. Platelets = 75 × 109/L; c. Hemoglobin = 8 g/dL; d. Serum albumin = 2.8 g/dL; e. Bilirubin = 3 ULN, ALT/AST = 2.5 UILN; if there is liver metastasis, ALT/AST = 5 times ULN; f. Creatinine clearance = 50 mL/min (Cockcroft-Gault, see Appendix III); g. Normal thyroid function. h. Adequate cardiac function, 2-dimensional cardiac ultrasound examination of the score (LVEF) > 50% - No history of serious drug allergy - Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test before enrollment - The subject voluntarily participates in this study. Sign the informed consent form, with good compliance and cooperation in follow-up Exclusion Criteria: - Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components - Presence of any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; complete remission of asthma in childhood, no intervention after adulthood can be included; patients with asthma requiring bronchodilators for medical intervention can not be included) - Patients are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other effective hormones), and continue to use 2 times before enrollment - Pregnant or lactating women - Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or effectively resected in situ cervical cancer and/or breast cancer - Patients prone to infection and poor blood glucose control - Incomplete important imaging examination and incomplete record of adverse reactions - Previous surgery, chemotherapy, targeted, radiotherapy and immune-related therapy - Other conditions that the investigator judges may affect the conduct of the clinical study and the judgment of the study results |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Hennan |
Lead Sponsor | Collaborator |
---|---|
Xuhua Duan |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | PFS is defined as time from the start of treatment to progression of disease or death. | Up to 1 year | |
Secondary | Objective response rate | The rate of participants that achieve either a complete response (CR) or a partial response (PR). | Up to 1 year | |
Secondary | Disease control rate | The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable. | Up to 1 year |
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