Actively Recruiting
D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC
Led by Guangdong Provincial People's Hospital · Updated on 2025-06-11
70
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm prospective single-center phase II study. Subjects are untreated resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. 70 subjects will be enrolled in this prospective observation aimed at evaluating the clinical efficacy and safety of D-BACE in combination with neoadjuvant chemotherapy and carelizumab in patients with resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. The treatment group regimen will be 3 cycles of D-BACE (DCB-loaded microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and carelizumab (the specific regimen of chemotherapy will be determined by the investigator, and platinum-containing two-agent chemotherapy will generally be used). Adverse events will be monitored throughout the trial and graded for severity according to NCI CTCAE version 5.0. Tissue and blood specimens will be dynamically collected during the course of treatment for translational research.
CONDITIONS
Official Title
D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Male or female aged 18 to 75 years
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable lesions according to RECIST version 1.1
- Able to provide tumor tissue specimen or biopsy sample of newly resected tumor
- PD-L1 immunohistochemistry testing completed at central lab during screening
- Submit formalin-fixed paraffin-embedded tissue blocks or non-stained tumor sections and pathology reports before treatment
- Tissue must be from core needle, excisional, or open biopsy
- Fresh paraffin sections recommended to be stored and transported in the dark
- Fresh tissue fixed in 10% neutral buffered formalin for 24 to 48 hours recommended
- Lung and other organ function sufficient to tolerate surgery as evaluated by surgeon
- Adequate organ function and laboratory screening within 7 days before therapy start
- Negative pregnancy test within 72 hours before treatment for women of childbearing age
- Female patients must be non-lactating
- Women must use effective contraception during treatment and for 6 months after last dose
- Male patients must use effective contraception during treatment and for 7 months after last dose
- Male patients must agree to avoid sperm donation during this period
You will not qualify if you...
- Stage I, IIIB/IIIC (N3), or stage IV NSCLC
- Previous immunotherapy, targeted therapy, chemotherapy, or other systemic anti-cancer treatments
- Allergy to contrast media
- Tumors with EGFR, ALK, ROS1, BRAF, HER-2, NTRK, MET, or RET alterations
- Active or suspected autoimmune disease except controlled conditions like type I diabetes or hypothyroidism requiring hormone replacement
- Active hepatitis B or hepatitis C infection
- History of arterial thrombosis within 6 months
- HIV positive or AIDS
- History of deep vein thrombosis, pulmonary embolism, or other major thromboembolism within 3 months
- Uncontrolled angina, arrhythmia, or congestive heart failure within 5 years
- Other active malignancies except adequately treated in situ or superficial cancers
- Contraindications to local treatment including surgery or intervention
- Psychosis or medical conditions causing treatment nonadherence
- Severe hypersensitivity to monoclonal antibodies
- Unwillingness to sign consent or participate in follow-up
- Abnormal laboratory values indicating poor bone marrow, liver, coagulation, or kidney function
- Prisoners or involuntarily detained individuals for mental or physical illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Guangdong provincial people's hospital
Guangzhou, Guangdong, China, 518000
Actively Recruiting
Research Team
W
Wei Cui, Dr
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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