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NCT04708067 · ClinicalTrials.gov registry record · Phase 1
Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma
A Phase 1 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT04708067: Active Phase 1 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04708067 is a Phase 1 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants, below the 43-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04708067, a Phase 1 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
AEs will be graded according to Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by patient incidence rates, therefore, in any tabulation, a patient contributes only once to the count for a given AE preferred term. The number and percentage of patients with any treatment-emergent AE will be summarized for all study patients combined.
Conditions Studied
Interventions
- PROCEDURE Biopsy
- RADIATION Hypofractionated Radiation Therapy
- DRUG Bintrafusp Alfa
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2027-02-02 |
| Phase | Phase 1 |
What the registry record for NCT04708067 still lists
NCT04708067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 43-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (95% lower).
The record links to 6 conditions, with Stage III Intrahepatic Cholangiocarcinoma AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Biopsy is the first listed.
NCT04708067 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04708067 about?
NCT04708067 is a clinical study titled "Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma". 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 radiat...
What is the current status of trial NCT04708067?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-08-31. Estimated completion is 2027-02-02.
What conditions does trial NCT04708067 study?
This clinical trial studies the following conditions: Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8, Metastatic Intrahepatic Cholangiocarcinoma.
What interventions are being tested in trial NCT04708067?
The interventions under investigation include: Biopsy (PROCEDURE), Hypofractionated Radiation Therapy (RADIATION), Bintrafusp Alfa (DRUG).
Who is sponsoring clinical trial NCT04708067?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04708067 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04708067's enrollment target sits among peer trials
2 9th of 8 the lowest of 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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