Actively Recruiting
Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic Gastrointestinal Malignancies Progressing on Immune Therapy
Led by University of California, San Francisco · Updated on 2025-10-06
28
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well radiation therapy works for treating metastatic gastrointestinal cancers that are spreading to other parts of the body. The study aims to find out if radiation therapy can slow or stop cancer growth in patients whose cancers are progressing despite immunotherapy treatment. It also explores whether targeting one tumor with radiation can help the immune system attack other tumors not directly treated by radiation. Patients receive radiation therapy consisting of five treatments over 5 to 9 calendar days, unless their disease worsens or they experience unacceptable side effects. The radiation dose is planned and delivered following standard protocols, with up to five treatment sites. After completing radiation therapy, patients continue to be followed for up to 36 months to monitor their response and health. During the study, participants undergo regular evaluations including tumor response assessments using specific response criteria, safety monitoring of side effects, and measurements of immune system effects and tumor DNA in the blood. Follow-up visits are scheduled at 14 days, 6 months, and periodically up to 36 months. Researchers will assess overall response rate, progression, survival, local tumor control, new metastatic lesions, and time to new therapies as part of the study outcomes.
CONDITIONS
Brief Title
Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically, cytologically, or radiographically confirmed metastatic gastrointestinal malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer)
- Receiving immunotherapy with progressive disease by RECIST criteria
- At least two metastases progressing by RECIST, with one safely unirradiated
- 1 to 5 sites suitable for palliative radiation therapy as determined by radiation oncologist
- Evaluation by radiation oncologist within 28 days before registration
- Adequate organ function for radiation therapy and immunotherapy
- Age 18 years or older
- Life expectancy over 6 months
- ECOG performance status 0 to 2 or Karnofsky score 50 or higher
- Women of child-bearing potential and men agree to use effective contraception during and after radiation therapy
- Ability to understand and sign informed consent
You will not qualify if you...
- Enrolled in immunotherapy clinical trial where radiation therapy is not allowed
- Received radiation therapy within 4 weeks before enrollment
- Using systemic corticosteroids or immunosuppressive drugs that reduce immunotherapy effect
- Radiation therapy contraindicated as determined by radiation oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for evaluation by radiation oncologist within 28 days before registration
Duration - 5 to 9 days
Participants undergo radiation therapy for metastatic gastrointestinal cancers in 5 treatments over 5 to 9 calendar days, unless disease progression or unacceptable toxicity occurs.
5 visits (in-person) for radiation therapy treatments
Duration - Up to 36 months
After completing radiation therapy, participants are followed up to monitor response, survival, and safety outcomes.
Visits at 14 days, 6 months, and additional visits up to 36 months
Trial Site Locations
Total: 2 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States, 94598
Not Yet Recruiting
Research Team
L
Luchia Andemicael
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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