NCT06775678

Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The eligible subjects were randomly divided into the experimental group and the control group according to the proportion of 1:1. The experimental group was treated with space fractionation radiotherapy for a single lesion, with a prescription dose of 800-1200cGy × 3f in the high-dose area and 100-300cGy × 5f in the low-dose area. All other irradiable metastatic foci were given low-dose radiotherapy (brain and bone metastases were given palliative radiotherapy according to clinical routine, but not within the range of low-dose radiotherapy). The prescription dose was 100-300cGy × 5f. Chemotherapy combined with immunotherapy was given during or within 1 week after radiotherapy. The control group only received conventional radiotherapy for chest or other lesions, followed by immunotherapy and chemotherapy according to the tumor stage, tolerance and genetic characteristics of the patients. Peripheral blood routine, immune cell (lymphocyte) subsets and related cytokines were detected before radiotherapy, on the day after radiotherapy and within 7 days after 1 cycle of immunotherapy. Before radiotherapy and after 1 cycle of immunotherapy, the metastatic focus was biopsied, fixed with 4% formaldehyde for 12-24 hours, dehydrated by gradient alcohol in the dehydrator, and finally embedded in paraffin to make wax blocks for preservation. The toxic and side effects of the treatment were recorded in detail, and the symptomatic treatment and detailed records can be made according to the severity. Patients with severe adverse reactions (SAE) will stop treatment and report to the research center for inclusion in the statistics. The toxicity and side effects were evaluated by CTCAE5.0 standard, and the long-term side effects were evaluated by RTOG long-term toxicity evaluation criteria.

Conditions

• Lung Cancers
• Radiation Treatment for Tumors

Interventions

Type	Name	Description
RADIATION	Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy	Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy
RADIATION	Conventional fractionated radiotherapy	Conventional fractionated radiotherapy

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-01-30
• Completion: 2028-01-28
• First posted: 2025-01-15
• Last updated: 2025-06-17

Locations

1 site across 1 country: China