Using radiation therapy to treat metastatic gastrointestinal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of radiation therapy in patients with metastatic gastrointestinal cancers who are also receiving immunotherapy. The primary goal is to see if radiation can change the disease status from progressive to stable or responsive. Secondary objectives include assessing overall response rates, time to progression, overall survival, and the safety of the treatment. The study also explores the immune response and changes in circulating tumor DNA following radiation therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• John Muir Medical Center-Walnut Creek
  Walnut Creek, California, United States Not yet recruiting

Study contacts

• Principal investigator: Mary Feng, MD — University of California, San Francisco
• Study coordinator: Luchia Andemicael
• Email: luchia.andemicael@ucsf.edu
• Phone: (415) 530-9814

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.