Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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. All other irradiated metastases will receive low - dose radiotherapy (100 - 300 cGy × 5 fractions), except for brain and bone metastases, which will be treated with palliative radiotherapy as per clinical routine. Immunotherapy will be administered during or within one week after radiotherapy.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- lattice radiation therapy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov