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

• Status: Recruiting
• Trial end date: 2024-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xuhua Duan
• Treatments: Gemcitabine; Oxaliplatin

Criteria

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