An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma
Phase 2
- Conditions
- Extrahepatic Cholangiocarcinoma
- Interventions
- Drug: Toripalimab, Gemcitabine,Oxaliplatin
- Registration Number
- NCT05448183
- Lead Sponsor
- Xuhua Duan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Toripalimab combined withTACE Toripalimab, Gemcitabine,Oxaliplatin -
- Primary Outcome Measures
Name Time Method Progression-free survival Up to 1 year PFS is defined as time from the start of treatment to progression of disease or death.
- Secondary Outcome Measures
Name Time Method Disease control rate Up to 1 year The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Objective response rate Up to 1 year The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Trial Locations
- Locations (1)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Hennan, China