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Can radiation kickstart the immune system against stubborn GI cancers?

NCT ID NCT04221893

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Metastatic anal canal carcinoma Metastatic colorectal carcinoma Metastatic esophageal carcinoma Metastatic gastric carcinoma Metastatic gastroesophageal junction adenocarcinoma Metastatic hepatocellular carcinoma Metastatic malignant digestive system neoplasm Metastatic small intestinal carcinoma Pancreatobiliary carcinoma Pathologic stage IV gastric cancer ajcc V8 Pathologic stage IVA esophageal adenocarcinoma ajcc V8 Pathologic stage IVA esophageal squamous cell carcinoma ajcc V8 Pathologic stage IVB esophageal adenocarcinoma ajcc V8 Pathologic stage IVB esophageal squamous cell carcinoma ajcc V8 Pathologic stage IVB gastroesophageal junction adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IV esophageal squamous cell carcinoma ajcc V8 Postneoadjuvant therapy stage IV gastric cancer ajcc V8 Postneoadjuvant therapy stage IV gastroesophageal junction adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IVA esophageal adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IVA esophageal squamous cell carcinoma ajcc V8 Postneoadjuvant therapy stage IVA gastroesophageal junction adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IVB esophageal adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IVB esophageal squamous cell carcinoma ajcc V8 Postneoadjuvant therapy stage IVB gastroesophageal junction adenocarcinoma ajcc V8 Stage IV adenocarcinoma of the gastroesophageal junction Stage IV anal cancer ajcc V8 Stage IV colorectal cancer ajcc V8 Stage IV esophageal adenocarcinoma Stage IV esophageal squamous cell carcinoma Stage IV gastric cancer Stage IV hepatocellular carcinoma ajcc V8 Stage IVA adenocarcinoma of the gastroesophageal junction Stage IVA colorectal cancer ajcc V8 Stage IVA esophageal adenocarcinoma Stage IVA esophageal squamous cell carcinoma Stage IVA gastric cancer Stage IVA hepatocellular carcinoma ajcc V8 Stage IVB colorectal cancer ajcc V8 Stage IVB esophageal adenocarcinoma Stage IVB esophageal squamous cell carcinoma Stage IVB gastric cancer Stage IVB gastroesophageal junction adenocarcinoma Stage IVB hepatocellular carcinoma ajcc V8 Stage IVC colorectal cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • John Muir Medical Center-Walnut Creek

    NOT_YET_RECRUITING

    Walnut Creek, California, 94598, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Email: •••••@•••••

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