Low-dose radiation to the intestines plus immunotherapy for cancer that spread to the liver
Tests gut radiation with immunotherapy in adults whose cancer has spread to the liver.
Plain-language title generated from the registry record
Registry title: Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced lung, colorectal or pancreatic cancer that has spread to the liver and has grown during earlier treatment. It tests low-dose radiation to the intestines together with immune therapy.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Advanced non-small cell lung cancer, colorectal cancer or pancreatic cancer with liver metastasis confirmed by biopsy or by 2 imaging scans. At least 1 measurable tumor in the liver. Brain metastases are allowed if stable on imaging. ECOG performance status 0-2. Expected survival of at least 3 months.
- Earlier treatment
- Lung cancer without EGFR/ALK/ROS1 gene changes: disease grew during first-line platinum-based chemotherapy plus a PD-1/PD-L1 inhibitor. Lung cancer with EGFR/ALK/ROS1 gene changes: disease grew during first-line targeted therapy. Colorectal or pancreatic cancer: disease grew during no more than 2 lines of therapy. No radiotherapy to the abdomen or pelvis within 6 months.
- Biomarker or test result
- Lung cancer cohorts: EGFR/ALK/ROS1 driver genes must be negative in one cohort and positive in the other.
Main reasons for not taking part
- Cannot have radiotherapy or immune checkpoint inhibitor therapy
- Serious unacceptable side effects from earlier immune checkpoint inhibitor therapy
- Active uncontrolled infection (bacterial, viral or fungal)
- Antibiotics, antifungals, antivirals or antiparasitics within the last 2 weeks
- Any tumor larger than 4 cm (1.6 in) across
Read by machine on 9 November 2026.
Where in China
- Hangzhou Cancer HospitalHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.).