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

  • STATUS
    Recruiting
  • End date
    May 15, 2024
  • participants needed
    45
  • sponsor
    Xuhua Duan
Updated on 25 July 2022
ct scan
measurable disease
metastasis
oxaliplatin
neutrophil count
liver metastasis
TACE
gemcitabine
Accepts healthy volunteers

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.

Details
Condition Extrahepatic Cholangiocarcinoma
Treatment Toripalimab, Gemcitabine,Oxaliplatin
Clinical Study IdentifierNCT05448183
SponsorXuhua Duan
Last Modified on25 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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