A Phase 2 interventional study of Intestinal Low-Dose Radiotherapy (ILDR) and PD-1/PD-L1 inhibitors in Liver Metastases, Non-Small Cell Lung Cancer and Colorectal Cancer (Diagnosis), sponsored by Bing Xia. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Bing Xia · Phase 2, Interventional, and Treatment
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.
Background: Liver metastasis is a common cause of death in advanced solid tumors and is associated with systemic immune suppression, leading to primary resistance to immune checkpoint inhibitors (ICIs). Preclinical and clinical evidence suggests that low-dose irradiation of the gut (ILDR, 1-3 Gy) can induce the migration of regulatory dendritic cells (mregDCs) from mesenteric lymph nodes to tumor-draining lymph nodes, cross-activate CD8+ T cells, and reprogram metabolism, thereby synergizing with ICIs. The Chen et al. (Cancer Cell 2025) study demonstrated that ILDR (1-3 Gy) significantly improved overall survival in patients receiving SABR plus anti-PD-L1, with an inverted U-shaped dose-response relationship. This study aims to prospectively evaluate the efficacy and safety of ILDR combined with ICIs in patients with liver metastases from solid tumors.
Study Design: This is a prospective, single-arm, single-center, exploratory cohort study. A one-sided exact binomial test will be used to compare the liver metastasis ORR with historical controls. The study plans to enroll 120 patients in three cohorts: Cohort A (NSCLC, driver gene negative, after first-line platinum-based chemotherapy plus PD-1/PD-L1 inhibitor progression, expected ORR 30% vs 10%), Cohort B (NSCLC, driver gene positive, after first-line targeted therapy progression, expected ORR 55% vs 35%), and Cohort C (colorectal/pancreatic cancer, after up to two lines of therapy progression, expected ORR 35% vs 15%). A two-stage execution rule with futility analysis will be applied.
Intervention: Patients will receive ILDR (1 Gy/1 fraction, IMRT/VMAT) targeting the jejunum, ileum, and mesentery (Dmean = 1 Gy) on Day 1. ICIs (PD-1/PD-L1 inhibitors) will be administered 24-72 hours after ILDR, every 3 weeks, for up to 2 years. Combined chemotherapy regimens include docetaxel for Cohort A, platinum-based doublet for Cohort B, and XELOX/FOLFOX/FOLFIRI/AG for Cohort C.
Endpoints: The primary endpoint is liver metastasis objective response rate (ORR) per RECIST v1.1. Secondary endpoints include overall ORR, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety (CTCAE 5.0), and multi-omics analysis (gut microbiome, metabolomics, immune profiling) of peripheral blood and stool samples.
Statistical Analysis: The primary endpoint will be analyzed using the Clopper-Pearson exact method for 95% CI. PFS and OS will be estimated using the Kaplan-Meier method. Multi-omics data will be analyzed using Wilcoxon signed-rank test, Mann-Whitney U test, LEfSe, PLS-DA, and Spearman correlation analysis.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
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Histologically or cytologically confirmed advanced solid malignancies:
Adequate major organ function within 7 days prior to enrollment:
Exclusion Criteria:
Patients with liver metastases from solid tumors receive a single fraction of intestinal low-dose radiotherapy (ILDR, 1 Gy/1F) on Day 1. Immune checkpoint inhibitors (PD-1/PD-L1) are administered 24-72 hours after ILDR, every 3 weeks, for up to 2 years. Combined chemotherapy is given based on tumor type: docetaxel for Cohort A (NSCLC driver gene negative), platinum-based doublet for Cohort B (NSCLC driver gene positive), and XELOX/FOLFOX/FOLFIRI/AG for Cohort C (colorectal/pancreatic cancer).
Radiation: Intestinal Low-Dose Radiotherapy (ILDR) · Drug: PD-1/PD-L1 inhibitors · Drug: Combined Chemotherapy
Single fraction of 1 Gy delivered to the intestine (jejunum, ileum, and mesentery) using IMRT/VMAT.
Also known as: ILDR
Administered 24-72 hours after ILDR, every 3 weeks, for up to 2 years.
Also known as: ICIs
Regimens based on tumor type: docetaxel (Cohort A), platinum-based doublet (Cohort B), or XELOX/FOLFOX/FOLFIRI/AG (Cohort C).
Also known as: Systemic Chemotherapy
Objective Response Rate (ORR) of Liver Metastases
Proportion of patients achieving complete response (CR) or partial response (PR) in liver metastatic lesions, as assessed by RECIST v1.1.
Time frame: Every 6 weeks (± 3 days) until disease progression, death, or up to 24 months.
Overall Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) in all target lesions, assessed by RECIST v1.1.
Time frame: Every 6 weeks (± 3 days) until disease progression, death, or up to 24 months.
Disease Control Rate (DCR) of Liver Metastases
Proportion of patients achieving CR, PR, or stable disease (SD) in liver metastatic lesions.
Time frame: At 6, 12, and 24 weeks after ILDR.
Overall Disease Control Rate (DCR)
Proportion of patients achieving CR, PR, or SD in all target lesions.
Time frame: At 6, 12, 24 weeks and every 6 weeks thereafter, until disease progression, death, or up to 24 months.
Progression-Free Survival (PFS)
Time from the first day of treatment to disease progression or death from any cause, whichever occurs first.
Time frame: From the first day of treatment to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
Overall Survival (OS)
Time from the first day of treatment to death from any cause.
Time frame: Up to 3 years.
Incidence of Adverse Events (AEs)
Frequency and severity of adverse events graded according to CTCAE v5.0.
Time frame: From informed consent to 30 days after the last dose.
Changes in Peripheral Blood Immune Landscape, Transcriptomics, and Metabolomics
Changes in immune cell subsets, gene transcription profiles, immune receptor repertoire, metabolomics, and cytokines in peripheral blood.
Time frame: Baseline, 24-48 hours after ILDR, and Day 1 of each ICIs cycle (each cycle is 21 days).
Changes in Gut Microbiome and Metabolomics
Changes in gut microbiome composition (metagenomics) and metabolites (metabolomics) in stool samples.
Time frame: Baseline, 24-48 hours after ILDR, and Day 1 of each ICIs cycle (each cycle is 21 days).
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2029, 30 months later.
Of 678 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 81. This study's planned 30 months is below that.
Counting every sponsor, half of 970 studies reached it within 48 months; a quarter within 30 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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