Tiny trial tests Radiation-Immunotherapy cocktail for tough bile duct cancer
NCT ID NCT04708067
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This early-phase trial tested a combination of focused radiation and an immunotherapy drug called bintrafusp alfa in just 2 patients with advanced bile duct cancer that had spread. The goal was to find the safest dose and see if the combo could help control the cancer. The study is no longer recruiting, and results are not yet available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bintrafusp alfa (immunotherapy drug) and hypofractionated radiation therapy
- What this could lead to
- If it works, this could point toward a new combination treatment for advanced bile duct cancer that is hard to treat.
- What could go wrong
- This is a very early Phase 1 trial with only 2 patients, so results may not apply broadly. The combination may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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2 people
The number who actually took part.
- Started
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Aug 2021
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must be male or female \>= 18 years of age * Patients with histologically or cytologically confirmed intrahepatic cholangiocarcinoma. There must be at least two measurable tumors. One larger mass that will be radiated and a secondary metastatic site that is amenable to biopsies * Patients must have received at least one standard first-line chemotherapy regimen or have refused chemotherapy * Patients with measurable disease assessed at baseline by computed tomography (CT) (or magnetic resonance imaging \[MRI\] where CT is contraindicated) will be entered in this study * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky \> 70) * Leukocytes \>= 3,000 cells/mm\^3 * Absolute neutrophil count \>= 1,500 cells/mm\^3 * Platelets \>= 100,000 cells/mm\^3 * Hemoglobin \>= 9 g/dl (no blood transfusions within 4 weeks prior to enrollment) * Total bilirubin \< 1.5 x institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x IULN without liver metastasis, =\< 5 x IULN for patients with liver metastasis * Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Women of childbearing potential (defined as not post-menopausal for 65 days or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation * All female patients of childbearing potential (defined as not post-menopausal for 65 days or no previous surgical sterilization) must agree to use adequate birth control during study treatment and for 90 days after the last dose of study drug and have a negative serum pregnancy test at screening * Fertile males must be willing to employ adequate means of contraception during study treatment and for 3 months after the last dose of study drug * Male subjects must agree to refrain from sperm donation during the study and for 125 days after the last dose of study drugs * Ability to read and/or understand the details of the study and provide written evidence of informed consent as approved by Institutional Review Board (IRB)/ Scientific Review Committee (SRC) Exclusion Criteria: * Patients who are pregnant or lactating * Patients with uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3 months of initiation of therapy * Patients with recent bacterial, viral, or fungal infection(s) requiring systemic antibiotic therapy within one month of enrolling * Patient has undergone major surgery within 4 weeks prior to day 1 of treatment in this study. Diagnostic or minimally invasive surgery (i.e., done to obtain a biopsy for diagnosis without removal of an organ or to place an abdominal spacer) are acceptable at physician discretion * Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to study entry weeks * Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug * Serious psychiatric or medical conditions that could interfere with treatment * Major bleeding in the last 4 weeks * Receipt of prior immune checkpoint inhibitors (e.g., anti-CTLA-4, anti-programmed cell death receptor 1, anti-programmed cell death ligand 1 \[anti-PD-L1\], and any other antibody or drug specifically targeting T-cell costimulation) * Receiving an immunologically based treatment for any reason, including chronic use of systemic steroid at doses \>= 7.5 mg/day prednisone equivalent within 14 days prior to the first dose of study treatment. Use of inhaled or topical steroids or systemic corticosteroids \< 7.5 mg is permitted * Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication or any unresolved toxicity (\> grade 1) from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity. Prior treatment with nitrosoureas (e.g., carmustine or lomustine) require a 6-week washout prior to the first dose of study treatment * Untreated central nervous system (CNS) metastases, or CNS metastases that have progressed (e.g., evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases). Subjects with treated and clinically stable CNS metastases and off all corticosteroids for at least 2 weeks are eligible * Any active or inactive autoimmune process (e.g. rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) or who are receiving systemic therapy for an autoimmune or inflammatory disease * Note: Exceptions include subjects with vitiligo, hypothyroidism stable on hormone replacement, controlled asthma, type I diabetes, Graves' disease, or Hashimoto's disease, or with medical monitor approval
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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