Low-dose radiation to the intestines plus immunotherapy for cancer that spread to the liver

Trial details

Who runs it

Bing Xia

Trial code

NCT07875465

Record updated

15 October 2026

Original description

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.Read full original descriptionShow less

Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in the Treatment of Liver Metastases From Solid Tumors: A Prospective Cohort Study

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.

Inclusion: 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: 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; Use of antibiotics, antifungals, antivirals, or antiparasitics within 2 weeks prior to enrollment; Active uncontrolled systemic bacterial, viral, or fungal infection; Any lesion burden with a maximum diameter > 4 cm; Other standard exclusion criteria (e.g., pregnancy, lactation, severe comorbidities, etc.).

ClinicalTrials.gov NCT07875465