An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma

Xuhua Duan

Status and phase

Enrolling

Phase 2

Conditions

Extrahepatic Cholangiocarcinoma

Treatments

Drug: Toripalimab, Gemcitabine,Oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT05448183

ChiECRCT20220189

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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