Actively Recruiting
Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-04-29
30
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or progressive disease.
- Age 18 years or older on the day of signing informed consent.
- No prior radiotherapy to the proposed site, or last radiotherapy at least 6 months ago.
- Karnofsky Performance Status score of 70 or higher.
- At least one measurable lesion per RECIST 1.1. Previously irradiated lesions qualify only if significant progression post-radiotherapy.
- Life expectancy greater than 3 months.
- Adequate organ and bone marrow function, including marrow (ANC ≥1.5×10⁹/L, platelets ≥80×10⁹/L, hemoglobin ≥9 g/dL), liver (bilirubin ≤1.5× upper limit normal, ALT/AST ≤1.5× upper limit normal), kidney (serum creatinine ≤1.5× upper limit normal or creatinine clearance ≥50 ml/min, blood urea nitrogen ≤200 mg/L), and coagulation (INR ≤1.5× upper limit normal, PTT ≤1.5× upper limit normal).
- Recovery from prior therapy-related adverse events to grade 1 or baseline.
- Willingness to use appropriate contraception.
- No radiotherapy contraindications as judged by the radiation oncologist.
- Agreement to receive both immunotherapy and radiotherapy.
You will not qualify if you...
- Active central nervous system 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 life expectancy under 3 months.
- Evidence of interstitial lung disease or active non-infectious pneumonia requiring steroid treatment.
- History of pulmonary fibrosis, pulmonary artery hypertension, or severe irreversible airway obstruction.
- Presence of peripheral neuropathy.
- Severe organ dysfunction likely to make radiotherapy intolerable.
- Known allergy to study drugs or severe allergic reaction to any PD-1 monoclonal antibody.
- Serious infection within 4 weeks prior to study treatment or recent antibiotic use within 2 weeks, except for prophylactic antibiotics.
- Known or suspected active autoimmune disease, except for vitiligo, cured childhood asthma, or well-controlled type 1 diabetes on insulin.
- History of allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant.
- Pregnant or breastfeeding women.
- Any other condition considered a valid reason for disqualification by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine
Cangzhou, Hebei, China, 061000
Actively Recruiting
3
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
N
Ningbo Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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