Solid CancersPhase 2SFRT-IM-P2NCT07058948
Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors
A Phase 2 study testing lattice radiation therapy in people with Solid Cancers and Radiotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers, Radiotherapy, Immune Checkpoint Inhibitor
- What is being tested?
- lattice radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- No prior radiotherapy to the proposed site, or last radiotherapy ≥6 months ago.
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- KPS score ≥70.
- At least one measurable lesion per RECIST 1.1. Previously irradiated lesions qualify only if significant progression post - radiotherapy.
- Life expectancy >3 months.
- Adequate organ and bone marrow function:
- Marrow: ANC ≥1.5×10⁹/L, platelets ≥80×10⁹/L, hemoglobin ≥9 g/dL;
- Liver: Total bilirubin ≤1.5× upper limit of normal (ULN), ALT/AST ≤1.5× ULN;
- Kidney: Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 ml/min, blood urea nitrogen ≤200 mg/L;
- Coagulation: INR ≤1.5× ULN, PTT ≤1.5× ULN.
- Recovery from prior therapy - related adverse events (≤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.
Who cannot join
- 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.
- Severe organ dysfunction (e.g., hepatic, cardiopulmonary failure) that is likely to make radiotherapy intolerable.
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- Known allergy to study drugs or excipients, or a history of severe allergic reaction to any PD - 1 monoclonal antibody.
- Serious infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; or receipt of oral or intravenous antibiotics within 2 weeks prior to study treatment. Patients receiving prophylactic antibiotics (e.g., for urinary tract infections or chronic obstructive pulmonary disease exacerbations) are eligible.
- Known or suspected active autoimmune disease (e.g., uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis). Exceptions: patients with vitiligo, cured childhood asthma; patients with 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 that the investigator deems a valid reason for disqualification based on the protocol.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Jing Yu Pro, Doctor, 86-10-63016616, yujing026@ccmu.edu.cn
Jing Yu, Doctor
- Recruiting
Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine
Cangzhou, Hebei, 061000
Yunchuan Sun Pro, Doctor, +86 317 2078600, sunyunchuan8210@163.com
Yunchuan Sun, Doctor
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Ningbo Liu, +8615602036608, liuningbo@tjmuch.com
About this study
Official title: A Phase II Prospective, Open-Label, Single-Arm Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With Immunotherapy in Patients With Advanced Solid Tumors
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.
Read the detailed description
This Phase II clinical trial investigates the combination of lattice radiation therapy (LRT) and immunotherapy in patients with advanced or metastatic solid tumors. LRT, a spatially fractionated radiotherapy technique, creates alternating high - and low - dose regions within the tumor to enhance local control and reduce toxicity to surrounding tissues.
Eligible patients will receive treatment using a medical linear accelerator. Within the largest tumor's gross tumor volume (GTV), 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 edge and a volume ratio of 1% - 10% of the GTV.
For a single lesion, the D95 of the GTV will be ≥1 Gy per fraction, and the D95 of the LRT target will be 8 - 12 Gy per fraction, while keeping the single - fraction dose to organs at risk as low as possible. All other irradiated metastases will receive low - dose radiotherapy at 100 - 300 cGy × 5 fractions. Brain and bone metastases will be treated with palliative radiotherapy as per clinical routine and are not included in the low - dose radiotherapy. Immunotherapy will be administered during or within one week after radiotherapy.
The study will monitor patients for treatment - related toxicities, immune - related adverse events, and assess treatment efficacy through imaging studies and biomarker analysis. The results will provide insights into the effectiveness and safety of combining LRT with immunotherapy for advanced solid tumors.
- Conditions
- Solid Cancers, Radiotherapy, Immune Checkpoint Inhibitor, Lung Cancer
- Being tested
- lattice radiation therapy
- Keywords
- spatially fractionated radiotherapy, solid cancers, immune checkpoint inhibitor
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lattice radiation therapyRadiation
Eligible patients will receive treatment using a medical linear accelerator. Within the largest tumor's gross tumor volume (GTV), 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 edge and a volume ratio of 1% - 10% of the GTV.
For a single lesion, the D95 of the GTV will be ≥1 Gy per fraction, and the D95 of the LRT target will be 8 - 12 Gy per fraction, while keeping the single - fraction dose to organs at risk as low as possible. All other irradiated metastases will receive low - dose radiotherapy at 100 - 300 cGy × 5 fractions. Brain and bone metastases will be treated with palliative radiotherapy as per clinical routine and are not included in the low - dose radiotherapy. Immunotherapy will be administered during or within one week after radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Eligible patients in this Phase II trial will undergo specific - dose irradiation using a medical linear accelerator. Within the largest tumor's gross tumor volume (GTV), 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 edge and a volume ratio of 1% - 10% of the GTV.
For a single lesion, the D95 of the GTV will be ≥1 Gy per fraction, and the D95 of the LRT target will be 8 - 12 Gy per fraction, while keeping the single - fraction dose to organs at risk as low as possible. All other irradiated metastases will receive low - dose radiotherapy at 100 - 300 cGy × 5 fractions. Brain and bone metastases will be treated with palliative radiotherapy as per clinical routine and are not included in the low - dose radiotherapy. Immunotherapy will be administered during or within one week after radiotherapy. Receives: Radiation: lattice radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The primary endpoint is the objective response rate, measuring tumor reduction usingRECIST v1.1 criteria.
Measured: Assessed at 6 weeks post-treatment initiation
Secondary outcomes (1)
Adverse Events
Incidence and grading of Adverse Events (AEs) and Serious Adverse Events (SAEs) (assessed using the NCI CTCAE v5.0 criteria), including abnormalities in vital signs, electrocardiograms, and laboratory tests
Measured: During and up to 1year post - treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058948
- Sponsor's protocol ID
- E20250717
- Acronym
- SFRT-IM-P2
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No