An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma
Primary Purpose
Extrahepatic Cholangiocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab, Gemcitabine,Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Toripalimab combined withTACE
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival
PFS is defined as time from the start of treatment to progression of disease or death.
Secondary Outcome Measures
Objective response rate
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Disease control rate
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05448183
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuhua Duan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toripalimab combined withTACE
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Toripalimab, Gemcitabine,Oxaliplatin
Intervention Description
Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), combined withTACE (Gemcitabine 1000mg/m2 , Oxaliplatin 135mg/m2) in a cycle of 3 weeks(q3w).
Primary Outcome Measure Information:
Title
Progression-free survival
Description
PFS is defined as time from the start of treatment to progression of disease or death.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Objective response rate
Description
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Time Frame
Up to 1 year
Title
Disease control rate
Description
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua xu Duan, Doctor
Phone
0086-13523402912
Email
xuhuaduan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua xu Duan, Doctor
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Hennan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuhua Duan
Phone
+8613523402912
Email
xuhuaduan@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma
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