RecruitingPhase 2NCT07058948

Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

30 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Radiotherapy Immune Checkpoint Inhibitor Solid Cancers

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. 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized type of radiation therapy called spatially fractionated radiotherapy (SFRT) — which delivers radiation in a grid-like pattern rather than uniformly — combined with immunotherapy for people with advanced solid tumors that cannot be surgically removed and have no other remaining standard treatment options. **You may be eligible if...** - You have been diagnosed with an advanced solid tumor (confirmed by biopsy) - Standard treatment options have been exhausted or are not suitable for you - A multidisciplinary tumor team has determined surgery is not an option - You are in good enough health to receive treatment - You are 18 years of age or older **You may NOT be eligible if...** - You have active autoimmune disease requiring ongoing immune-suppressing treatment - You have serious infections or organ dysfunction - You have had recent major surgery - You are pregnant or breastfeeding - You have previously received treatment that would make SFRT unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONlattice radiation therapy

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.

Locations(3)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine

Cangzhou, Hebei, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07058948

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