Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy:a Phase II, Single Arm, Prospective Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age between18 years and 75 years.

• Histologic or cytologic confirmation of extensive-stage small cell lung cancer.

• Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.

• Presence of at least one measurable lesion (according to RECIST v1.1).

• ECOG performance status of 0 or 1.

• Life expectancy of at least 3 months.

• Adequate bone marrow, liver and kidney function.

• Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value

Locations
Other Locations
China
HenanCH
RECRUITING
Zhengzhou
Contact Information
Primary
Yang Liu
zlyyliuyang1440@zzu.edu.cn
13676961186
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-03-20
Participants
Target number of participants: 47
Treatments
Experimental: Thoracic Radiotherapy
Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov

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