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Background and purpose <p>Bulky solid tumors present significant therapeutic challenges. Spatially fractionated radiotherapy (SFRT), a technique delivering alternating high- and low-dose subvolumes, alters the tumor microenvironment while minimizing toxicity. This phase II trial assesses the efficacy and safety of SFRT combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic agents in advanced malignancies.</p> Methods and materials <p>This prospective phase II trial enrolled 34 patients with bulky solid tumors between October 2024 and July 2025. All patients underwent SFRT using GRID, LATTICE, or Stereotactic central/core ablative radiation therapy techniques. Multimodal therapy, incorporating pre-radiotherapy administration of granulocyte-macrophage colony-stimulating factor and thymalfasin, as well as concurrent ICIs and anti-angiogenic agents during SFRT, was administered according to clinical recommendations and patient preferences. The endpoints were treatment-related adverse events and the objective response rate (ORR). In addition, a prognostic analysis was performed to identify factors associated with clinical outcomes.</p> Results <p>Among the 37 treatment courses in 34 patients, 4 patients did not complete the planned therapy, and 1 was lost to follow-up. The median follow-up duration was 6.0 months. Of the 32 evaluable lesions from patients who completed the study, the ORR was 65.63% (21/32). Of the 22 evaluable patients, 5 (22.73%) exhibited abscopal effects. Common adverse events included anemia (18.92%), followed by skin/mucositis and pneumonia, each occurring in 10.81% of patients.</p> Conclusions <p>This phase II trial demonstrates that the multimodal approach of SFRT combined with ICIs and anti-angiogenic agents is a promising strategy for bulky solid tumors, while highlighting the need for larger trials to validate long-term efficacy and refine personalized treatment protocols. (Registry: ClinicalTrials.gov, TRN: NCT06775678, Registration date: 1 October 2024)</p>

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Preliminary results from a phase II trial of spatially fractionated radiotherapy combined with immunotherapy and anti-angiogenic therapy in patients with bulky solid tumors: early evidence of promising efficacy and favorable safety

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月30日

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  • Yuntao Zhou,
  • Yanwei Li,
  • Hui Zhu,
  • Siyi Yang,
  • Chengwen Yang,
  • Shengpeng Jiang,
  • Shiping Shen,
  • Lujun Zhao,
  • Jing Luo,
  • Zhiyong Yuan,
  • Ningbo Liu

摘要

Background and purpose

Bulky solid tumors present significant therapeutic challenges. Spatially fractionated radiotherapy (SFRT), a technique delivering alternating high- and low-dose subvolumes, alters the tumor microenvironment while minimizing toxicity. This phase II trial assesses the efficacy and safety of SFRT combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic agents in advanced malignancies.

Methods and materials

This prospective phase II trial enrolled 34 patients with bulky solid tumors between October 2024 and July 2025. All patients underwent SFRT using GRID, LATTICE, or Stereotactic central/core ablative radiation therapy techniques. Multimodal therapy, incorporating pre-radiotherapy administration of granulocyte-macrophage colony-stimulating factor and thymalfasin, as well as concurrent ICIs and anti-angiogenic agents during SFRT, was administered according to clinical recommendations and patient preferences. The endpoints were treatment-related adverse events and the objective response rate (ORR). In addition, a prognostic analysis was performed to identify factors associated with clinical outcomes.

Results

Among the 37 treatment courses in 34 patients, 4 patients did not complete the planned therapy, and 1 was lost to follow-up. The median follow-up duration was 6.0 months. Of the 32 evaluable lesions from patients who completed the study, the ORR was 65.63% (21/32). Of the 22 evaluable patients, 5 (22.73%) exhibited abscopal effects. Common adverse events included anemia (18.92%), followed by skin/mucositis and pneumonia, each occurring in 10.81% of patients.

Conclusions

This phase II trial demonstrates that the multimodal approach of SFRT combined with ICIs and anti-angiogenic agents is a promising strategy for bulky solid tumors, while highlighting the need for larger trials to validate long-term efficacy and refine personalized treatment protocols. (Registry: ClinicalTrials.gov, TRN: NCT06775678, Registration date: 1 October 2024)