Can radiation kickstart the immune system against stubborn GI cancers?
NCT ID NCT04221893
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study is for people with advanced gastrointestinal cancers that are growing despite immunotherapy. Researchers want to see if adding targeted radiation to one tumor can help the immune system attack other tumors throughout the body. About 28 participants will receive radiation while continuing their current immunotherapy. The goal is to slow or stop cancer progression and improve treatment response.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Apr 2028
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer). 2. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria. 3. Patients must have at least one metastasis which is progressing as per RECIST criteria. 4. Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example: * Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea * At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise 5. Evaluation by a radiation oncologist within 28 days of study registration. 6. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care. 7. Age \>= 18 years. 8. Life expectancy exceeding 6 months. 9. Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \>= 50. 10. Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after completion of radiation therapy. Contraception requirements during the follow-up period of 6 months will be according to standard of care for immunotherapy administration. a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required. 11. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted. 2. Administration of radiation therapy within 4 weeks prior to study enrollment. 3. Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician. 4. Radiation therapy is contraindicated as adjudicated by the radiation oncologist.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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John Muir Medical Center-Walnut Creek
NOT_YET_RECRUITINGWalnut Creek, California, 94598, United States
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
Contact Email: •••••@•••••
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