Actively Recruiting
A Phase II Study Evaluating Spatially Fractionated Radiotherapy Combined With Immunotherapy in Patients With Advanced Solid Tumors
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-04-29
30
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of lattice radiation therapy (LRT) and immunotherapy in patients with advanced or metastatic solid tumors. This Phase II clinical trial aims to assess the safety and effectiveness of this combined approach. LRT is a specialized radiotherapy technique that delivers alternating high and low radiation doses within the tumor to improve control while reducing damage to surrounding tissues. Participants will receive treatment using a medical linear accelerator. High-dose targets called LRT targets, sized 0.5 to 3 cm in diameter, will be placed within the largest tumor's gross tumor volume (GTV), spaced 2.0 to 5.0 cm apart, avoiding blood vessels and at least 1 cm from the GTV edge. Single lesions will receive 1 Gy or more per fraction to the GTV and 8 to 12 Gy per fraction to the LRT targets, with minimal dose to nearby organs. Other metastases will get low-dose radiotherapy over five fractions, except brain and bone metastases, which receive standard palliative care. Immunotherapy will be given during or within one week after radiotherapy. During the study, patients will be monitored for treatment-related toxicities and immune-related side effects. Effectiveness will be assessed through imaging and biomarker analysis, with the primary outcome being the objective response rate at 6 weeks after starting treatment. Adverse events will be followed for up to one year. Participants' organ and bone marrow function will also be regularly evaluated to ensure safety throughout the trial.
CONDITIONS
Brief 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
- No available or tolerated standard therapy with stable or progressive disease
- Age 18 years or older at consent
- No prior radiotherapy to treatment site within last 6 months
- Karnofsky Performance Status score of 70 or higher
- At least one measurable lesion per RECIST 1.1
- Life expectancy greater than 3 months
- Adequate organ and bone marrow function
- Recovery from prior therapy-related adverse events (Grade 1 or baseline)
- Willingness to use appropriate contraception
- No radiotherapy contraindications
- Agreement to receive both immunotherapy and radiotherapy
You will not qualify if you...
- Active central nervous system metastases or spinal cord compression
- Severe comorbidities affecting treatment completion or life expectancy under 3 months
- Interstitial lung disease or active pneumonia requiring steroids
- History of pulmonary fibrosis, pulmonary artery hypertension, or severe airway obstruction
- Presence of peripheral neuropathy
- Severe organ dysfunction making radiotherapy intolerable
- Allergy to study drugs or severe reaction to PD-1 monoclonal antibodies
- Recent serious infection or antibiotic use within 2 weeks before treatment
- Active autoimmune diseases except certain controlled conditions
- History of allogeneic organ or stem cell transplant
- Pregnant or breastfeeding women
- Any other condition judged by investigator to disqualify participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 fractions of radiotherapy over approximately 1 week, with immunotherapy during or within 1 week after radiotherapy
Participants receive lattice radiation therapy targeting high-dose regions within the largest tumor and low-dose radiotherapy to other metastases, combined with immunotherapy administered during or within one week after radiotherapy.
Daily visits for radiotherapy over 1 week and additional visits for immunotherapy administration
Duration - Up to 1 year post-treatment
Participants are monitored for treatment-related toxicities, immune-related adverse events, and treatment efficacy through imaging and biomarker analysis.
Visits at 6 weeks post-treatment initiation and periodic visits up to 1 year
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
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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