Could a tiny dose of radiation reboot cancer immunotherapy?
NCT ID NCT07164690
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase II trial tests whether a single low dose of radiation to all visible tumors can help immunotherapy work again in people with advanced esophageal cancer that has stopped responding to standard treatment. Thirty-two adults will receive the radiation and continue their original immunotherapy. The study will track how long the cancer stays controlled and whether the combination is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-dose radiation therapy
- What this could lead to
- If successful, this approach could help restore the effectiveness of immunotherapy in patients whose esophageal cancer has stopped responding to standard treatment.
- What could go wrong
- This is a small, early-phase trial with only 32 participants and no comparison group. The benefit may be modest, and there are risks like fistula or bleeding from radiation.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age≥18 years old; * ECOG score 0-1; * Histologically or cytologically confirmed esophageal squamous cell carcinoma that is locally advanced (unresectable) or metastatic (AJCC/TNM 8th edition). * Progression during or after one prior systemic first-line regimen that contained both a platinum-based chemotherapy and a PD-1/PD-L1 inhibitor (progression must be documented radiologically or clinically). Patients who received neoadjuvant/adjuvant therapy containing a PD-1/PD-L1 inhibitor are considered first-line failures if progression/recurrence occurs during or within 6 months after completion of that therapy. * At least one measurable lesion per RECIST 1.1 within 4 weeks before enrollment. NOTE: a previously irradiated lesion cannot serve as a target lesion unless clear progression after radiotherapy is documented. * Life expectancy ≥ 3 months. * Adequate organ function within 1 week before enrollment: * Hematologic: Hb ≥ 80 g/L; WBC ≥ 3.0 × 10⁹/L or ANC ≥ 1.5 × 10⁹/L; platelets ≥ 100 × 10⁹/L. * Hepatic: total bilirubin ≤ 1.5 × ULN (direct bilirubin ≤ ULN if total \> 1.5 × ULN); ALT/AST ≤ 2.5 × ULN. * Renal: serum creatinine \< 1.5 × ULN or creatinine clearance ≥ 50 mL/min; BUN ≤ 200 mg/L; albumin ≥ 30 g/L. * Ability to understand and provide written informed consent. Exclusion Criteria: * Active autoimmune disease (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, vasculitis). * Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis. * Tumor invasion into adjacent organs (aorta or trachea) with high risk of bleeding or fistula; prior esophageal stent placement. * Other malignancies within the past 2 years (except adequately treated basal-cell carcinoma, cervical carcinoma in situ, etc.). * Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or uncontrolled arrhythmia. * Any condition that, in the investigator's opinion, could interfere with study results or increase patient risk. * Mixed small-cell histology. * Pregnant or breastfeeding women. * Congenital or acquired immunodeficiency, HIV infection, prior organ or allogeneic stem-cell transplantation. * Active HBV, HCV, or tuberculosis infection. * Prior tumor vaccine or any live vaccine within 4 weeks (inactivated influenza vaccine is allowed). * Concurrent use of other immunosuppressive agents, chemotherapy, investigational drugs, or chronic corticosteroids. * Psychiatric illness, substance abuse, or social issues that could compromise compliance. * Prior intolerance, hypersensitivity, or contraindication to PD-1/PD-L1 inhibitors or chemotherapy components.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Radiation plus targeted antibody tested in older head and neck cancer patients
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- Can a new drug boost immunotherapy against Hard-to-Treat stomach cancer?