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

NCT ID: NCT05448183

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2024-05-15

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.

Conditions

Extrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toripalimab combined withTACE

Group Type: EXPERIMENTAL

Toripalimab, Gemcitabine,Oxaliplatin

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuhua Duan

OTHER

Sponsor Role: lead

Responsible Party

Xuhua Duan

Associate chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hua xu Duan, Doctor

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Zhengzhou University

Locations

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Hennan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua xu Duan, Doctor

Role: CONTACT

xuhuaduan@163.com

0086-13523402912

Facility Contacts

Xuhua Duan

Role: primary

xuhuaduan@163.com

+8613523402912

Other Identifiers

ChiECRCT20220189

Identifier Type: -

Identifier Source: org_study_id