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

Extrahepatic Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448183
• Other study ID #: ChiECRCT20220189
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: July 2022
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Hua xu Duan, Doctor
• Phone: 0086-13523402912
• Email: xuhuaduan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Extrahepatic Cholangiocarcinoma

Intervention

Drug:
• Toripalimab, Gemcitabine,Oxaliplatin
Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), combined withTACE (Gemcitabine 1000mg/m2 , Oxaliplatin 135mg/m2) in a cycle of 3 weeks(q3w).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Hennan

Sponsors (1)

Lead Sponsor	Collaborator
Xuhua Duan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	PFS is defined as time from the start of treatment to progression of disease or death.	Up to 1 year
Secondary	Objective response rate	The rate of participants that achieve either a complete response (CR) or a partial response (PR).	Up to 1 year
Secondary	Disease control rate	The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.	Up to 1 year