NCT07875465Not yet recruitingPhase 2
Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases
Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in the Treatment of Liver Metastases From Solid Tumors: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 27 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- Bing Xia
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07875465
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From Oct 2026 to the primary completion date, Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active uncontrolled systemic bacterial, viral, or fungal infection.
Other
- Any lesion burden with a maximum diameter \> 4 cm.
- Other standard exclusion criteria (e.g., pregnancy, lactation, severe comorbidities, etc.).
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hangzhou Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.