Actively Recruiting
Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer
Led by Ruijin Hospital · Updated on 2024-11-19
20
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1/PD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.
CONDITIONS
Official Title
Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed, untreated, and surgically resectable non-small cell lung cancer stage II-IIIA (excluding squamous cell carcinoma or EGFR mutation)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Satisfactory preoperative lab tests and adequate lung function for surgery
- Patients agree to and sign informed consent
You will not qualify if you...
- Pancoast tumor, squamous cell carcinoma, large-cell carcinoma, or sarcomatoid carcinoma
- Active or history of autoimmune disease
- Need for systemic prednisone or other immunosuppressive treatments
- History of symptomatic interstitial lung disease
- Allergy to study drug components
- Pregnant or breastfeeding women
- Men with female partners not willing to use contraception
- Prior chemotherapy, anti-angiogenesis therapy, or immunotherapy for this or other malignancies
- Previous treatment for non-small cell lung cancer
- Mental or psychological conditions impairing study participation or understanding
- Major hemoptysis within past 4 weeks or tumor invading/near major vessels
- High risk of major bleeding
- History of arterial thrombotic events, esophageal varices, peptic ulcers, wounds, or bone fractures
- Prior malignancies
- HIV, HBV, HCV infection or active pulmonary tuberculosis
- Medical conditions that may make study drug administration unsafe or affect toxicity interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
H
Hecheng Li, MD, PhD
CONTACT
Y
Yuyan Zheng, MD
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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