Clinical trial · Interventional
Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.
Conditions
Conditions (44)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Anal Canal Carcinoma | Anal Canal Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Esophageal Carcinoma | Esophageal Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Gastric Carcinoma | Gastric Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Malignant Digestive System Neoplasm | Malignant Digestive System Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy (RT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation therapy (RT)
- description
- Patients undergo radiation therapy for a total of 5 treatments over 5-9 calendar days in the absence of disease progression or unacceptable toxicity. Target prescription dose will be 30 Gy in 5 fractions and each treatment site (up to 5) will undergo standard Department-approved treatment planning, quality-assurance, and delivery protocols
- interventionNames
- Radiation: Radiation Therapy (RT)
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- Up to 8 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
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