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NOT YET RECRUITING
NCT07875465
PHASE2

Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases

Sponsor: Bing Xia

View on ClinicalTrials.gov

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

Interventions

RADIATION

Intestinal Low-Dose Radiotherapy (ILDR)

Single fraction of 1 Gy delivered to the intestine (jejunum, ileum, and mesentery) using IMRT/VMAT.

DRUG

PD-1/PD-L1 inhibitors

Administered 24-72 hours after ILDR, every 3 weeks, for up to 2 years.

DRUG

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