Clinical Trial Assessing the Efficacy of Abscopal Effect Induced by SBRT and Immunotherapy in Advanced NSCLC
- Sponsor
- Xinqiao Hospital of Chongqing
- Study ID
- NCT04238169
- Phase
- PHASE2
- Status
- Completed
Conditions
- Non-Small-Cell Lung Cancer Stage IV
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUG7.5mg/kg once every three weeks
- Toripalimab — DRUG240 mg once every three weeks
- SBRT — RADIATION30-50Gy/5F（2-4 lesions）
Study Details
This is a prospective, multicenter, open-label study to observe the effect of SBRT and immunotherapy combined with Bevacizumab or not in stage IV non-squamous non-small cell lung cancer (NSCLC) with previously failed after chemotherapy.
Key Dates
- First listed
- Jan 23, 2020
- Start date
- Sep 1, 2020
- Status verified
- Feb 2024
- Primary completion
- Dec 31, 2022
- Completion
- Dec 31, 2023
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SBRT+ToripalimabImmunotherapy：Toripalimab: 240 mg once every three weeks，Until progress of disease or investigators determine that clinical benefit is no longer available or there are intolerable toxicity. SBRT：30-50Gy/5F（2-4 locations).
- Experimental: SBRT+Bevacizumab+ToripalimabImmunotherapy：Toripalimab: 240 mg once every three weeks，Until progress of disease or investigators determine that clinical benefit is no longer available or there are intolerable toxicity. SBRT：30-50 Grays(Gy) in 5 fractions（2-4 locations）. Bevacizumab：7.5mg/kg once every three weeks.
Primary Outcome Measure
Objective response rate [ Time Frame: Up to 6 months ]