Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Malignant Solid Tumors

Launched by CHUANGZHEN CHEN · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced cancers that have spread to other parts of the body and have not responded well to previous immunotherapy treatments. The researchers are testing whether giving a very low dose of radiation to the intestines, combined with immunotherapy drugs called PD-1 or PD-L1 inhibitors, can help the immune system better fight these resistant tumors. The idea is that this low-dose radiation might change the environment in the gut to improve how well immunotherapy works.

People who may be eligible for this study are adults aged 18 to 80 with metastatic solid tumors (like lung or esophageal cancer) that have continued to grow despite prior immunotherapy. They need to be in reasonably good health (able to carry out daily activities) and have at least one tumor that can be measured to track treatment effects. Patients should not have received certain types of radiation recently or have serious infections or organ problems. During the trial, participants will receive a small dose of radiation to a part of the small intestine followed by immunotherapy within 24 hours, and this treatment may continue for up to two years. The study will carefully monitor how well the treatment works, any side effects, and changes in immune response and gut bacteria. This research aims to find better ways to treat cancers that are resistant to current immunotherapies and to identify markers that might predict who will benefit the most.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years, ≤80 years, regardless of gender.
• • ECOG level 0-2.
• • Expected life span\>3 months.
• • At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria.
• • Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression.
• • Patients should not be considered eligible for surgical treatment.
• • Patients with brain metastases that are assessed as clinically stable after treatment through repeated CT and/or MRI scans are eligible.
• • Patients have complete clinical and pathological information.
• • Patients should not be borthered by any psychological, family, social or geographical conditions that may hinder compliance with the research protocol.
• • Patients should be able to understand the informed consent form, voluntarily participate, and sign the informed consent form.
• • Other indicators accord with the general inclusion criteria for clinical trials.
• Exclusion Criteria:
• • Patients with contraindications to radiation therapy and immunotherapy.
• • Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.).
• • Patients who were assessed as hyperprogressive disease (HPD).
• • Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment.
• • The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss).
• • Patients with active uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.
• • Significant liver or kidney dysfunction (i.e., laboratory values \>3 times the upper limit of normal).
• • Active hepatitis B, hepatitis C, HIV, or syphilis.
• • Brain disorders, symptomatic central nervous system (CNS) or meningeal metastases, or impaired cognitive function.
• • Hypersensitivity to any drug included in the trial.
• • Drug and/or alcohol abuse.
• • Pregnant or breastfeeding women.
• • Concurrent participation in another therapeutic clinical trial.
• • Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within ≤14 days after intervention).
• • Major surgery within 30 days.
• • Use of antibiotics, antifungals, antivirals, antiparasitics, or probiotics within 4 weeks before enrollment.