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

Xuhua Duan1 site in 1 country45 target enrollmentJune 15, 2022

ConditionsExtrahepatic Cholangiocarcinoma

InterventionsToripalimab, Gemcitabine,Oxaliplatin

Overview

Phase: Phase 2
Intervention: Toripalimab, Gemcitabine,Oxaliplatin
Conditions: Extrahepatic Cholangiocarcinoma
Sponsor: Xuhua Duan
Enrollment: 45
Locations: 1
Primary Endpoint: Progression-free survival
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 15, 2022

End Date

May 15, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xuhua Duan

Responsible Party

Sponsor Investigator

Principal Investigator

Xuhua Duan

Associate chief physician

The First Affiliated Hospital of Zhengzhou University

Eligibility 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

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