NCT07058948
Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors
Recruiting · Phase 2 · Tianjin Medical University Cancer Institute and Hospital · registry updated 2026-04-29
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Lattice radiation therapy (LRT) is a spatially fractionated radiotherapy technique that creates alternating high - and low - dose areas within a tumor to enhance local control and reduce toxicity to surrounding tissues. This study aims to evaluate the effectiveness and safety of combining LRT with immunotherapy in patients with advanced or metastatic solid tumors, through a Phase II clinical trial. Patients will receive specific - dose irradiation using a medical linear accelerator. Within the GTV of the largest tumor, spheres (0.5 - 3 cm in diameter) will be created as high - dose targets (LRT targets), spaced 2.0 - 5.0 cm apart. The LRT targets must be drawn within the GTV, avoiding blood vessels, with a margin of at least 1 cm from the GTV margin, and a volume ratio of 1% - 10% of the GTV. For a single lesion, the D95 of the GTV will be ≥1 Gy/fraction, and the D95 of the LRT target will be 8 - 12 Gy/fraction, with minimal possible single - fraction doses to organs at risk....
Inclusion
- Inclusion Criteria:\*\*
- Signed informed consent.
- Histologically or cytologically confirmed malignant solid tumor.
- Advanced solid tumor unsuitable for surgery as determined by a multidisciplinary tumor board or consulting physicians.
- No available standard therapy or inability to tolerate it, with imaging and clinical assessment showing stable disease (SD) or progressive disease (PD).
- Age ≥18 years on the day of signing informed consent.
Exclusion
- Exclusion Criteria:\*\*
- Active central nervous system (CNS) metastases, carcinomatous meningitis, or spinal cord compression.
- Severe comorbidities such as myocardial infarction within 6 months, severe arrhythmias, or psychosis that may affect treatment completion or result in a life expectancy of \<3 months.
- Evidence of interstitial lung disease or active/non - infectious pneumonia (e.g., drug - induced, radiation - induced) requiring steroid treatment.
- History of pulmonary fibrosis, pulmonary artery hypertension, or severe irreversible airway obstruction.
- Presence of peripheral neuropathy.