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ACTIVE NOT RECRUITING
NCT04708067
PHASE1

Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Official title: "Window of Opportunity" Phase I Trial of Focal Radiotherapy and Bintrafusp Alfa In Patients With Advanced Intrahepatic Cholangiocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2

Start Date

2021-08-31

Completion Date

2027-02-02

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DRUG

Bintrafusp Alfa

Given IV

PROCEDURE

Biopsy

Undergo biopsy

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States