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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 | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT05448183•Xuhua Duan

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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
+1 more criteria

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

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Hennan, China

Key Dates

Start Date

June 15, 2022

Primary Completion Date

May 15, 2023

Completion Date

May 15, 2024

Last Updated

July 7, 2022

Enrollment

ESTIMATED participants

Conditions

Extrahepatic Cholangiocarcinoma

Interventions

Toripalimab, Gemcitabine,Oxaliplatin

DRUG

Contacts

Hua xu Duan, Doctor

CONTACT

0086-13523402912 xuhuaduan@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma

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