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Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases
Sponsor: Bing Xia
Summary
This study aims to evaluate the effectiveness and safety of combining low-dose radiotherapy to the intestines with immune checkpoint inhibitors (ICIs) in patients with liver metastases from solid tumors. Liver metastases often create an "immune desert" that makes immunotherapy less effective. Recent research has shown that low-dose irradiation of the gut (1 Gy) can reshape the gut microbiome and activate the immune system, potentially reversing resistance to immunotherapy. This is a prospective, single-arm, single-center cohort study. We plan to enroll 120 patients with liver metastases from non-small cell lung cancer (NSCLC), colorectal cancer, or pancreatic cancer. All participants will receive a single low dose of radiotherapy to the intestine (1 Gy), followed by standard immune checkpoint inhibitors and chemotherapy. The main goal of this study is to see how well the liver metastases respond to this combined treatment. We will also monitor survival, side effects, and changes in the gut bacteria and blood immune markers to understand how this treatment works. This strategy may provide a low-cost, low-toxicity new option for patients whose liver metastases have stopped responding to standard immunotherapy.
Official title: Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in the Treatment of Liver Metastases From Solid Tumors: A Prospective Cohort Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-10
Completion Date
2031-04
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Intestinal Low-Dose Radiotherapy (ILDR)
Single fraction of 1 Gy delivered to the intestine (jejunum, ileum, and mesentery) using IMRT/VMAT.
PD-1/PD-L1 inhibitors
Administered 24-72 hours after ILDR, every 3 weeks, for up to 2 years.
Combined Chemotherapy
Regimens based on tumor type: docetaxel (Cohort A), platinum-based doublet (Cohort B), or XELOX/FOLFOX/FOLFIRI/AG (Cohort C).
Locations (1)
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China