Clinical trial NCT05448183: An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extrahepatic Cholangiocarcinoma
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Progression-free survival
timeFrame: Up to 1 year
Secondary outcomes:
measure: Objective response rate
timeFrame: Up to 1 year
measure: Disease control rate
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Hennan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Hua xu Duan, Doctor
role: STUDY_DIRECTOR
References: