NCT06914050

Hypofractionated Radiotherapy Followed by Chemo-immunotherapy Induction Therapy

An Exploratory Study on the Treatment of Limited-stage Small Cell Lung Cancer With Induction Therapy of Adebrelimab Combined With Chemotherapy Followed by Thoracic Radiotherapy After Hypofractionated Radiotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Radiotherapy can activate local and systemic immune responses through a variety of mechanisms, which can enhance anti-tumor immune effects. The dose fractionation pattern of radiotherapy has an important influence on the occurrence of immune-induced effects. Stereotactic body radiation therapy (SBRT) has obvious advantages in activating interferon effects and inducing abscopal effects. SBRT combined with immunity can enhance the abscopal effect induced by radiotherapy and play a synergistic role. The 8Gy×3 fractionation scheme is currently the most widely used stereotactic radiotherapy scheme. Because we conducted this study, the primary lesion received large-fraction partial tumor irradiation and then received adebrelimab combined with chemotherapy induction treatment for 2 cycles, followed by sequential chest radiotherapy for the treatment of limited-stage small cell lung cancer, to explore the effectiveness and safety.

Conditions

• Lung Cancer, Small Cell
• Limited-stage Small Cell Lung Cancer (LS-SCLC)

Interventions

Type	Name	Description
DRUG	Adebrelimab	Induction therapy：Adebrelimab, 1200mg, d1, q3w, 2 cycles; Maintenance therapy：Adebrelimab, 1200mg, d1, q3w, until disease progression or unbearable toxicity.
DRUG	EC/EP	Chemotherapy: standard chemotherapy EC/EP
RADIATION	SBRT	8Gy\*3
RADIATION	Chest radiotherapy	Chest radiotherapy: conventional fractionation mode 2Gy QD total dose 60Gy or 1.5Gy BID total dose 45Gy, according to the patient's physical condition, concurrent EP or EC chemotherapy can be considered

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2028-04-01
• First posted: 2025-04-06
• Last updated: 2025-04-25