CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 84 target
Drug / intervention
Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Histopathological evidence of small cell lung cancer, lung adenocarcinoma, or lung squamous cell carcinoma
  • ✓Prior immunotherapy with disease progression
  • ✓Radiotherapy site not previously irradiated or ≥6 months since last radiotherapy
Key exclusion· 6
  • ✕Lesions unsuitable for radiotherapy (malignant pleural effusion, ascites, meningeal metastasis)
  • ✕Serious comorbidities such as myocardial infarction within 6 months, severe arrhythmia, or mental illness
  • ✕Severe organ dysfunction (liver failure, cardiopulmonary failure) unable to tolerate radiotherapy
  • ✕Current severe infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06775678
NCT06775678Phase 2RecruitingOn TrackUpdated 12mo ago
CompareCT.gov

A Single-centre Phase II Clinical Study of Spatially Fragmentation Radiotherapy Combined With Low-dose Radiotherapy for Reversal of Immunotherapy Combined With Chemotherapy Resistance in Locally Advanced Inoperable or Advanced Non-small Cell Lung Cancer

Tianjin Medical University Cancer Institute and Hospital·interventional·Posted Jan 15, 2025·Updated Jun 17, 2025

In Brief

A Phase 2 clinical trial evaluating Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy and Conventional fractionated radiotherapy for Lung Cancers and Radiation Treatment for Tumors. Currently recruiting, targeting 84 participants across 1 site.

Detailed Summary

The purpose of this study was to evaluate the effect of immunotherapy combined with spatial fractionation radiotherapy and low dose radiotherapy on the prognosis of patients with advanced lung cancer under specific dose regimens (spatial fractionation radiotherapy: high dose region: 800-1200cGy × 3f, low dose region: 100-300cGy × 5f; low dose radiotherapy area: 100-300cGy × 5f). Through the phase II clinical trial, to determine the efficacy and safety of the combined treatment model in advanced lung cancer and its effect on the immune microenvironment of patients, so as to provide scientific basis for the optimization of treatment regimen for advanced lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancers, Radiation Treatment for Tumors
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
2025202620272028
First PostedJan 15, 2025
Enrollment StartOct 1, 2024
Primary CompletionJan 30, 2027
Study CompletionJan 28, 2028
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 1.5 years agoPrimary completion in 7 months

Interventions

Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapyradiation

Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy

Conventional fractionated radiotherapyradiation

Conventional fractionated radiotherapy