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

NCT05448183 | Unknown Phase 2

• 1 other identifier: ChiECRCT20220189
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  PFS is defined as time from the start of treatment to progression of disease or death.

  Up to 1 year

Secondary Outcomes (2)

• Objective response rate

  Up to 1 year

• Disease control rate

  Up to 1 year

Study Arms (1)

Toripalimab combined withTACE

EXPERIMENTAL

Drug: Toripalimab, Gemcitabine,Oxaliplatin

Interventions

Toripalimab, Gemcitabine,Oxaliplatin DRUG

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

Toripalimab combined withTACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuhua Duan: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Hennan, 450000, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

toripalimab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Hua xu Duan, Doctor

  The First Affiliated Hospital of Zhengzhou University

  STUDY DIRECTOR

Central Study Contacts

Hua xu Duan, Doctor

CONTACT

0086-13523402912; xuhuaduan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: June 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2024
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

CN (1)