Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06379087

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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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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