NCT04840758

Stereotactic Ablation Radiotherapy Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer

A Prospective Single-arm Single-center Clinical Study：Assessment of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer (sMPLC)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) combined with Sintilimab in early inoperable synchronous Multiple Primary Lung Cancer (sMPLC)

Detailed description

Stereotactic ablation radiotherapy (SABR) was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor. Immunotherapy was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles.

Conditions

• Multiple Primary Lung Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Ablation Radiotherapy	Stereotactic ablation radiotherapy was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor。
DRUG	Sintilimab	Sintilimab was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-12-01
• Completion: 2023-04-01
• First posted: 2021-04-12
• Last updated: 2021-04-12