Extrahepatic Cholangiocarcinoma
Conditions
Brief summary
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.
Interventions
DRUGToripalimab, Gemcitabine,Oxaliplatin
Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), combined withTACE (Gemcitabine 1000mg/m2 , Oxaliplatin 135mg/m2) in a cycle of 3 weeks(q3w).
Sponsors
Xuhua Duan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Up to 1 year | PFS is defined as time from the start of treatment to progression of disease or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Up to 1 year | The rate of participants that achieve either a complete response (CR) or a partial response (PR). |
| Disease control rate | Up to 1 year | The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable. |
Countries
China
Contacts
Primary ContactHua xu Duan, Doctor
Outcome results
None listed