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Monoclonal Antibodies
Radiation + Immunotherapy for Bile Duct Cancer
Phase 1
Waitlist Available
Led By Eugene J Koay
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky > 70)
Patients must have received at least one standard first-line chemotherapy regimen or have refused chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-treatment
Awards & highlights
Study Summary
This trial is to find the best dose of radiation and a new immunotherapy drug for bile duct cancer that has spread.
Who is the study for?
This trial is for adults with advanced bile duct cancer who have tried at least one chemotherapy or refused it. They must have two measurable tumors, be in good physical condition, and agree to use birth control. People can't join if they have autoimmune diseases, recent infections requiring antibiotics, major surgery within 4 weeks, received certain treatments recently, untreated brain metastases, are pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial tests a combination of hypofractionated radiation therapy (higher doses over a short period) and bintrafusp alfa (an immunotherapy drug). It aims to find the best dose and see how well this combo works against advanced intrahepatic cholangiocarcinoma by helping the immune system attack cancer.See study design
What are the potential side effects?
Possible side effects include typical reactions from radiation like skin irritation and fatigue as well as immune-related effects from bintrafusp alfa such as flu-like symptoms, potential organ inflammation due to an overactive immune response, and infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or have minor restrictions in physical activity.
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I have undergone or refused initial chemotherapy.
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I am 18 years old or older.
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My kidney function, measured by creatinine levels or clearance, is normal.
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My liver function tests are within the required range.
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I have bile duct cancer with at least two tumors that can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Local progression free survival (LPFS)
Objective response rate
Overall survival (OS)
+1 moreOther outcome measures
Biomarker analysis
Side effects data
From 2022 Phase 2 trial • 107 Patients • NCT0332480280%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (hypofractionated radiation, bintrafusp alfa)Experimental Treatment3 Interventions
Patients undergo hypofractionated radiation therapy 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 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Biopsy
2014
Completed Phase 4
~850
Bintrafusp Alfa
2021
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,766 Total Patients Enrolled
Eugene J KoayPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major bleeding in the last 4 weeks.I am fully active or have minor restrictions in physical activity.I have undergone or refused initial chemotherapy.I haven't taken cancer drugs in the last 21 days and don't have major side effects from past treatments.I am 18 years old or older.I do not have any mental health or medical conditions that could affect my treatment.I am capable of having children and agree to use birth control during the study.I am not on high-dose steroids or immune treatments.I agree not to donate sperm during and for 125 days after the study.My brain metastases are stable, and I haven't taken steroids for 2 weeks.I have an autoimmune disease or am receiving treatment for one.I have previously received treatments that boost the immune system to fight cancer.My disease can be measured by CT or MRI scans.My kidney function, measured by creatinine levels or clearance, is normal.My liver function tests are within the required range.I have bile duct cancer with at least two tumors that can be measured.I agree to use birth control during and for 3 months after the study.I have not had major surgery in the last 4 weeks.I am able to have children and agree to use birth control during and after the study.My hemoglobin level is 9 g/dl or higher and I haven't had a blood transfusion in the last 4 weeks.I haven't had cancer treatment or experimental therapy in the last 2 weeks.I haven't needed antibiotics for an infection in the last month.I do not have uncontrolled heart problems or a recent heart attack.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (hypofractionated radiation, bintrafusp alfa)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to join this scientific research project?
"Affirmative. The details posted on clinicaltrials.gov verify that this medical study, which was first publicised on August 31st 2021, is actively looking for recruits. 15 participants need to be enrolled from 1 particular health facility."
Answered by AI
What other investigations involving Hypofractionated Radiation Therapy have been conducted?
"Currently, Hypofractionated Radiation Therapy is the subject of 22 ongoing trials with 2 reaching Phase 3. Of those 285 trial sites across the globe, several are located in Houston, Texas."
Answered by AI
Has Hypofractionated Radiation Therapy gained regulatory acceptance?
"Based on the limited prior clinical data concerning Hypofractionated Radiation Therapy, our team determined that it was worth a score of 1."
Answered by AI
How many people have enrolled in this experiment?
"Indeed, the clinicaltrials.gov website confirms that this medical experiment is still seeking participants; it was initially posted on August 31st 2021 and most recently modified on August 18th 2022. This study requires 15 patients to be recruited from one site."
Answered by AI
Has a research study of this kind ever been attempted before?
"Hypofractionated Radiation Therapy has been under investigation since 2016 when Merck Sharp & Dohme LLC first sponsored a trial with 829 participants. Subsequent Phase 1 clinical trials have granted it drug approval, and there are currently 22 active studies related to the treatment being carried out in 59 cities across 21 nations."
Answered by AI
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