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Clinical Trial Summary

This phase I trial is to find out the best dose, possible benefits, and/or side effects of hypofractionated radiation therapy and bintrafusp alfa in treating patients with bile duct cancer that has spread to other places in the body (advanced intrahepatic cholangiocarcinoma). Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Immunotherapy with bintrafusp alfa, a bifunctional fusion protein composed of the monoclonal antibody avelumab and TGF-beta, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The combination of hypofractionated radiation therapy and bintrafusp alfa may help to control intrahepatic cholangiocarcinoma.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To examine the safety of bintrafusp alfa in combination with hypofractionated radiation therapy for patients with advanced intrahepatic cholangiocarcinoma and recommend a phase II radiation dose. SECONDARY OBJECTIVES: I. To estimate objective response rate, local progression free survival, progression free survival, overall survival with the study regimen. II. To correlate expression of TGF-beta related pathways with clinical outcomes. III. To examine intratumoral pharmacodynamic changes in the immune microenvironment using paired biopsies before and after therapy with the study agents. EXPLORATORY OBJECTIVE: I. To correlate immune biomarkers from pre- and post-treatment tissue, blood, and stool with clinical study endpoints. OUTLINE: This is a dose de-escalation study of radiation therapy followed by a dose-expansion study. Patients undergo hypofractionated radiation therapy once daily (QD) on weekdays (Monday-Friday) for 15 fractions in the absence of disease progression or unacceptable toxicity. Beginning 1 week after completion of radiation therapy, patients receive bintrafusp alfa intravenously (IV) over 1 hour on day 1. Cycles repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for up to 2 years. ;


Study Design


Related Conditions & MeSH terms

  • Cholangiocarcinoma
  • Locally Advanced Intrahepatic Cholangiocarcinoma
  • Metastatic Intrahepatic Cholangiocarcinoma
  • Stage III Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IV Intrahepatic Cholangiocarcinoma AJCC v8

NCT number NCT04708067
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date August 31, 2021
Completion date February 2, 2027

See also
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Active, not recruiting NCT04251715 - mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma Phase 2