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

NCT07875465 · tracked via the Priya Life Science China tracker

Sponsor

Bing Xia

Phase

Phase 2

Started

2026-10

Last updated

2026-10-15

Condition(s) studied

Liver MetastasesNon-Small Cell Lung CancerColorectal Cancer (Diagnosis)Pancreatic Cancer MetastaticSolid Tumors

Investigational drug(s) / intervention(s)

Intestinal Low-Dose Radiotherapy (ILDR)PD-1/PD-L1 inhibitorsCombined Chemotherapy

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).

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years, male or female. * ECOG performance status 0-2. * Expected survival ≥ 3 months. * Histologically or cytologically confirmed advanced solid malignancies: * Cohort A: Advanced NSCLC with negative driver genes (EGFR/ALK/ROS1), disease progression during first-line platinum-based doublet chemotherapy combined with PD-1/PD-L1 inhibitors. * Cohort B: Advanced NSCLC with positive driver genes (EGFR/ALK/ROS1), disease progression during first-line targeted therapy. * Cohort C: Advanced colorectal or pancreatic cancer, disease progression during no more than two lines of therapy. * Confirmed liver metastasis (pathologically or by 2 imaging modalities). * At least 1 measurable intrahepatic target lesion per RECIST v1.1. * Brain metastases are permitted if radiologically stable. * Adequate major organ function within 7 days prior to enrollment: * Hematology: Absolute neutrophil count ≥ 1.5 × 10\^9/L, Platelets ≥ 100 × 10\^9/L, Hemoglobin ≥ 90 g/L. * Liver: Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome or liver metastasis); AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN for liver metastasis). * Kidney: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula). Exclusion Criteria: * Contraindications to radiotherapy and immune checkpoint inhibitor therapy. * Prior unacceptable toxicity following immune checkpoint inhibitor therapy. * History of abdominopelvic radiotherapy within 6 months prior to enrollment. * Prior anti-tumor adverse events not recovered to CTCAE 5.0 Grade ≤ 1. * Active uncontrolled systemic bacterial, viral, or fungal infection. * Use of antibiotics, antifungals, antivirals, or antiparasitics within 2 weeks prior to enrollment. * Any lesion burden with a maximum diameter \> 4 cm. * Other standard exclusion criteria (e.g., pregnancy, lactation, severe comorbidities, etc.).

Primary outcome measure(s)

Objective Response Rate (ORR) of Liver Metastases — Every 6 weeks (± 3 days) until disease progression, death, or up to 24 months.
Proportion of patients achieving complete response (CR) or partial response (PR) in liver metastatic lesions, as assessed by RECIST v1.1.

Trial sites (1)

Facility	City	Region	Status
Hangzhou Cancer Hospital	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07875465 on ClinicalTrials.gov ↗ ← All trials in China