A Prospective Phase II Controlled Study to Evaluate the Impact of Thymosin Alpha 1 on the Completion Rate of Consolidation Immunotherapy After Radical Radiochemotherapy for Locally Advanced Non-Small Cell Lung Cancer
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• aged ≥18 years old
• histologically confirmed locally advanced and unresectable NSCLC;
• no prior radiotherapy or surgery;
• with the life expectancy over 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• adequate bone marrow and hepatic and renal functions;
• informed consent
Locations
Other Locations
China
Sun yat-sen university cancer center
RECRUITING
Guangzhou
Contact Information
Primary
Bo Qiu, Professor
qiubo@sysucc.org.cn
+86-020-87343031
Time Frame
Start Date: 2023-07-25
Estimated Completion Date: 2026-08
Participants
Target number of participants: 114
Treatments
Experimental: Concurrent Tα-1 group
In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.
Other: Control group
In control group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University