Gut radiation may revive immunotherapy in resistant cancers
NCT ID NCT06076135
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This phase 2 trial investigates whether a single, low dose of radiation to the small intestine can help the immune system recognize and attack tumors again in people with advanced solid cancers that have stopped responding to immunotherapy. Participants receive 1Gy of radiation to the jejunum and ileum, followed by their previous or adjusted PD-1/PD-L1 inhibitor. The study aims to see if this combination can shrink tumors or slow disease progression, and it also collects blood and stool samples to explore why some patients respond.
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 to the intestine (1Gy) plus PD-1/PD-L1 inhibitors
- What this could lead to
- If successful, this approach could offer a new way to re-sensitize tumors that have stopped responding to immunotherapy, potentially improving outcomes for patients with advanced cancer.
- What could go wrong
- This is a small, early-phase trial (24 participants) and the combination may not work for everyone. There is also a risk of side effects from both radiation and immunotherapy.
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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24 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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May 2026
- 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 to 80 years
- 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: 1. Age ≥18 years, ≤80 years, regardless of gender. 2. ECOG level 0-2. 3. Expected life span\>3 months. 4. At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria. 5. Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression. 6. The patient is considered ineligible for surgical treatment. 7. Patients with brain metastases assessed as clinically stable after treatment through repeated CT and/or MRI scans are eligible. 8. Patients have complete clinical and pathological information. 9. Any psychological, family, social or geographical conditions may hinder compliance with the research protocol. 10. Patients are able to understand the informed consent form, voluntarily participate, and sign the informed consent form. 11. Other indicators accord with the general inclusion criteria for clinical trials. Exclusion Criteria: 1. Patients with contraindications to radiation therapy and immunotherapy. 2. Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.). 3. Patients who were assessed as hyperprogressive disease (HPD). 4. Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment. 5. The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss). 6. Accompanied by severe infections. 7. Serious liver disease (such as cirrhosis), kidney disease, respiratory disease, or chronic system diseases such as uncontrollable diabetes and hypertension; Patients who cannot tolerate radiation therapy. 8. Clinical symptoms of brain metastases or meningeal metastasis. 9. The patients with known allergies or allergies to the test drug ingredients. 10. Substance/alcohol abuse. 11. Patients who are pregnant or planning to. 12. Patients participating in other clinical studies that may affect the efficacy/safety of this clinical study. 13. Patients who have undergone major surgical procedures within 30 days. 14. Patients who have received antibiotics, antifungal drugs, antiviral, antiparasitic drugs, or probiotics within 4 weeks.
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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.
Contacts and locations
Locations
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Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, 515031, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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