Radiation Therapy for Metastatic Gastrointestinal Cancers

This study is looking at how radiation therapy works for people with gastrointestinal cancers (like esophageal or stomach cancer) that have spread to other parts of the body (metastatic). Radiation therapy uses high-energy X-rays to kill cancer cells. You might be able to join if you are an adult with metastatic gastrointestinal cancer that is getting worse while you are already receiving immunotherapy (like a checkpoint inhibitor or CTLA4 inhibitor). The main goal is to see if radiation therapy can change your cancer's response from getting worse to becoming stable or shrinking. Researchers also want to see if treating one tumor with radiation can help your immune system fight other tumors in your body. This study plans to enroll 28 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 28 participants.
What's involved
You would undergo radiation therapy, which involves 5 treatments over 5-9 calendar days.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured for up to 8 weeks.

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NCT04221893

Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

Recruiting
NAAges 18+InterventionalTreatment
University of California, San Francisco
~28 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Radiation Therapy (RT)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over Up to 8 weeks
Stage IV Esophageal Adenocarcinoma
Stage IV Esophageal Squamous Cell Carcinoma
Stage IV Gastric Cancer
Stage IV Adenocarcinoma of the Gastroesophageal Junction
Stage IVA Esophageal Adenocarcinoma
Stage IVA Esophageal Squamous Cell Carcinoma
Stage IVA Gastric Cancer
Stage IVA Adenocarcinoma of the Gastroesophageal Junction
Stage IVB Esophageal Adenocarcinoma
Stage IVB Esophageal Squamous Cell Carcinoma
Stage IVB Gastric Cancer
Stage IVB Gastroesophageal Junction Adenocarcinoma
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 Anal Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8
Stage IV Hepatocellular Carcinoma AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVA Hepatocellular Carcinoma AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVB Hepatocellular Carcinoma AJCC v8
Stage IVC Colorectal Cancer AJCC v8
2 sites across 1 states
California2
  • Mary Feng, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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Eligibility criteria

Inclusion

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.
  • Overall response rate (ORR)Up to 8 weeks

    Proportion of patients who achieve as their best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 criteria: Stable disease (SD), partial response (PR), confirmed Complete Response (CR), or progressive disease (PD). Corresponding exact confidence intervals will be reported for the entire cohort and stratified by histologic subtype, programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) status, microsatellite instability (MSI), and organs treated if sample size allows. Patients with unevaluable or unknown response status will be considered nonresponders.