Actively Recruiting
Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC
Led by Ji Yongling · Updated on 2025-07-10
20
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.
CONDITIONS
Official Title
Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years old
- Diagnosed with early stage II-IIIA non-small cell lung cancer confirmed by tissue
- All tumors assessed as eligible for surgical removal
- Primary tumor suitable for hypofractionated radiotherapy
- Negative for EGFR, ALK, and ROS1 gene mutations in primary tumor or lymph node metastasis
- ECOG performance status of 0 or 1
- Expected survival longer than 1 year
- At least one measurable lesion per RECIST 1.1 criteria
- Females of childbearing potential agree to use contraception during study and for 3 months after, with a negative pregnancy test before enrollment; males agree to use contraception during study and for 3 months after
- Voluntarily consent to participate and able to comply with study requirements
- Suitable for study participation after multidisciplinary team discussion
You will not qualify if you...
- Primary tumor location unsuitable for hypofractionated therapy
- Small cell lung cancer or mixed tumors with small cell components
- History or presence of other cancers
- Prior anti-tumor treatments including chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Imaging showing tumor invasion of major blood vessels or presence of lung cavities or necrosis
- Hemoptysis, active bleeding, ulcers, intestinal perforation, or obstruction within 3 months before enrollment
- Previous or active interstitial lung disease or idiopathic pulmonary fibrosis
- Serious or uncontrolled systemic diseases such as unstable respiratory, cardiac, liver, or kidney conditions
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune checkpoint inhibitors
- Presence of large uncontrolled fluid accumulation such as pleural effusion or ascites
- Significant proteinuria or severe liver and kidney dysfunction
- Uncontrolled high blood pressure (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Need for systemic corticosteroids or immunosuppressive drugs within 14 days before first dose
- Recent thrombotic events like stroke or cerebral hemorrhage within 6 months
- Major surgery or trauma within 28 days before enrollment
- Pregnant or breastfeeding women
- Other reasons deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
M
Min Fang, PhD
CONTACT
Y
YongLing Ji, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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